| Code | Device name | Class | 21 CFR | 510(k) (3y) |
|---|
| FMH | Container, Specimen, Sterile | Class 1 | 21 CFR 864.3250 | 23 |
| HZI | Acid, Osmic | Class 1 | 21 CFR 864.4010 | |
| IAL | Iodine (Tincture) | Class 1 | 21 CFR 864.4010 | |
| IAM | Solution, Lugol'S | Class 1 | 21 CFR 864.4010 | |
| IAT | Syrup, Gum, Apathy'S | Class 1 | 21 CFR 864.4010 | |
| IAW | Collodion | Class 1 | 21 CFR 864.4010 | |
| IAY | Colchicine | Class 1 | 21 CFR 864.4010 | |
| IAZ | Heparin | Class 1 | 21 CFR 864.4400 | |
| IBA | Streptolysin O | Class 1 | 21 CFR 864.4400 | |
| IBB | Phytohemaglutinin M | Class 1 | 21 CFR 864.4010 | |
| IBC | Diastase | Class 1 | 21 CFR 864.4400 | |
| IBD | Hyaluronidase | Class 1 | 21 CFR 864.4400 | |
| IBE | Neuramininase (Sialidase) | Class 1 | 21 CFR 864.4400 | |
| IBF | Papain | Class 1 | 21 CFR 864.4400 | |
| IBG | Trypsin | Class 1 | 21 CFR 864.4400 | 2 |
| IBJ | Light, Microscope | Class 1 | 21 CFR 864.3600 | 9 |
| IBK | Microscope, Fluorescence/U.V. | Class 1 | 21 CFR 864.3600 | 1 |
| IBL | Microscope, Inverted Stage, Tissue Culture | Class 1 | 21 CFR 864.3600 | |
| IBM | Microscope, Phase Contrast | Class 1 | 21 CFR 864.3600 | 1 |
| IDL | Microtome, Accessories | Class 1 | 21 CFR 864.3010 | 5 |
| IDM | Microtome, Ultra | Class 1 | 21 CFR 864.3010 | 1 |
| IDN | Microtome, Freezing Attachment | Class 1 | 21 CFR 864.3010 | |
| IDO | Microtome, Rotary | Class 1 | 21 CFR 864.3010 | 5 |
| IDP | Microtome, Cryostat | Class 1 | 21 CFR 864.3010 | 1 |
| IDQ | Infiltrator | Class 1 | 21 CFR 864.3010 | |
| IDR | Ovens, Paraffin | Class 1 | 21 CFR 864.3010 | |
| IDS | Melting Pot, Paraffin | Class 1 | 21 CFR 864.3010 | 1 |
| IDT | Apparatus, Melting Point, Paraffin | Class 1 | 21 CFR 864.3010 | |
| IDW | Dispensers, Paraffin | Class 1 | 21 CFR 864.3010 | 1 |
| IDX | Sieves, Tissue | Class 1 | 21 CFR 864.3010 | |
| IDY | Bath, Flotation, Tissue | Class 1 | 21 CFR 864.3010 | |
| IDZ | Cassettes, Tissue | Class 1 | 21 CFR 864.3010 | 5 |
| IEG | Table, Slide Warming | Class 1 | 21 CFR 864.3010 | 1 |
| IEH | Lamps, Slide Warming | Class 1 | 21 CFR 864.3010 | |
| IEO | Processor, Tissue, Automated | Class 1 | 21 CFR 864.3875 | 12 |
| IER | Polyethylene Glycol (Carbowax) | Class 1 | 21 CFR 864.4010 | 1 |
| IEX | Gelatin | Class 1 | 21 CFR 864.4010 | |
| IEZ | Celloidin | Class 1 | 21 CFR 864.4010 | |
| IFB | Cytocentrifuge | Class 1 | 21 CFR 864.3300 | 3 |
| IFF | Solution, Decalcifier, Electrolytic | Class 1 | 21 CFR 864.4010 | |
| IFH | Solution, Zenker'S | Class 1 | 21 CFR 864.4010 | 2 |
| IFI | Sprays, Synthetic, Smear | Class 1 | 21 CFR 864.4010 | 1 |
| IFJ | Fixative, Richardson Glycol | Class 1 | 21 CFR 864.4010 | |
| IFL | Polyethylene Glycol Preservative | Class 1 | 21 CFR 864.4010 | |
| IFN | Solution, Orth'S | Class 1 | 21 CFR 864.4010 | |
| IFO | Solution, Newcomer'S | Class 1 | 21 CFR 864.4010 | |
| IFP | Formalin, Neutral Buffered | Class 1 | 21 CFR 864.4010 | 15 |
| IFQ | Formulations, Mercuric Chloride For Tissue | Class 1 | 21 CFR 864.4010 | 2 |
| IFS | Solution, Helly | Class 1 | 21 CFR 864.4010 | |
| IFT | Glutaraldehyde | Class 1 | 21 CFR 864.4010 | 1 |
| IFY | Gelatin-Formalin | Class 1 | 21 CFR 864.4010 | |
| IFZ | Gelatin For Specimen Adhesion | Class 1 | 21 CFR 864.4010 | 1 |
| IGB | Solution, Formalin-Sodium Acetate | Class 1 | 21 CFR 864.4010 | 1 |
| IGC | Formalin-Saline | Class 1 | 21 CFR 864.4010 | 2 |
| IGD | Solution, Formol Calcium | Class 1 | 21 CFR 864.4010 | |
| IGE | Solution, Formalin Ammonium Bromide | Class 1 | 21 CFR 864.4010 | 2 |
| IGF | Solution, Formalin-Alcohol-Acetic Acid | Class 1 | 21 CFR 864.4010 | 1 |
| IGG | Formaldehyde (Formalin, Formol) | Class 1 | 21 CFR 864.4010 | 7 |
| IGK | Solution, Clarke'S | Class 1 | 21 CFR 864.4010 | |
| IGM | Solution, Carnoy'S | Class 1 | 21 CFR 864.4010 | 3 |
| IGN | Fluid, Bouin'S | Class 1 | 21 CFR 864.4010 | 2 |
| IHJ | Blender, Sputum | Class 1 | 21 CFR 864.3010 | |
| IJZ | Oil, Clearing | Class 1 | 21 CFR 864.4010 | 1 |
| JCB | Detergent | Class 1 | 21 CFR 864.4010 | |
| JCC | Ph Buffer | Class 1 | 21 CFR 864.4010 | 7 |
| JCE | Solution, Isotonic | Class 1 | 21 CFR 864.4010 | 7 |
| KDT | Container, Specimen Mailer And Storage, Sterile | Class 1 | 21 CFR 864.3250 | 12 |
| KDW | Container, Specimen Mailer And Storage, Temperature Controlled, Steril | Class 1 | 21 CFR 864.3250 | 4 |
| KDX | Solution, Decalcifier, Acid Containing | Class 1 | 21 CFR 864.4010 | 8 |
| KDY | Agent, Chelating For Decalcification | Class 1 | 21 CFR 864.4010 | |
| KDZ | Device, Decalcifier, Electrolytic | Class 1 | 21 CFR 864.3010 | |
| KEE | Osmium Tetroxide | Class 1 | 21 CFR 864.4010 | |
| KEF | Paraformaldehyde | Class 1 | 21 CFR 864.4010 | |
| KEG | Lamps, Microscope | Class 1 | 21 CFR 864.3600 | |
| KEH | Micrometers, Microscope | Class 1 | 21 CFR 864.3600 | |
| KEI | Condensers, Microscope | Class 1 | 21 CFR 864.3600 | |
| KEJ | Stages, Microscope | Class 1 | 21 CFR 864.3600 | 1 |
| KEL | Adhesive, Albumin-Based | Class 1 | 21 CFR 864.4010 | 2 |
| KEM | Agent, Clearing | Class 1 | 21 CFR 864.4010 | 15 |
| KEO | Formulations, Paraffin, All | Class 1 | 21 CFR 864.4010 | 11 |
| KEP | Media, Mounting, Oil Soluble | Class 1 | 21 CFR 864.4010 | 3 |
| KEQ | Media, Mounting, Water Soluble | Class 1 | 21 CFR 864.4010 | 7 |
| KER | Container, Embedding | Class 1 | 21 CFR 864.3010 | 5 |
| KES | Coverslips, Microscope Slide | Class 1 | 21 CFR 864.3010 | 3 |
| KET | Filters, Cell Collection, Tissue Processing | Class 1 | 21 CFR 864.3010 | 5 |
| KEW | Slides, Microscope | Class 1 | 21 CFR 864.3010 | 8 |
| KEY | Stainer, Tissue, Automated | Class 1 | 21 CFR 864.3800 | 1 |
| KFL | Microtome, Sliding | Class 1 | 21 CFR 864.3010 | |
| KIM | Device For Sealing Microsections | Class 1 | 21 CFR 864.3400 | 1 |
| KIN | Slide Stainer, Contact Type | Class 1 | 21 CFR 864.3800 | 1 |
| KIO | Slide Stainer, Immersion Type | Class 1 | 21 CFR 864.3800 | 1 |
| KJG | Tube, Tissue Culture | Class 1 | 21 CFR 864.3010 | 1 |
| KPA | Slide Stainer, Automated | Class 1 | 21 CFR 864.3800 | 21 |
| LDW | Fixative, Acid Containing | Class 1 | 21 CFR 864.4010 | 4 |
| LDX | Fixative, Metallic Containing | Class 1 | 21 CFR 864.4010 | 1 |
| LDY | Fixative, Formalin-Containing | Class 1 | 21 CFR 864.4010 | 1 |
| LDZ | Fixative, Alcohol Containing | Class 1 | 21 CFR 864.4010 | 8 |
| LEA | Preservative, Cytological | Class 1 | 21 CFR 864.4010 | 4 |
| LEB | Mounting Media | Class 1 | 21 CFR 864.4010 | 5 |
| LEC | Grinder, Tissue | Class 1 | 21 CFR 864.3010 | |
| LIJ | Peroxidase Anti-Peroxidase Immunohistochemical Stain | Class 1 | 21 CFR 864.4400 | 2 |
| MJI | Specimen/Tissue, Identification Orientation | Class 1 | 21 CFR 864.3010 | |
| MPQ | Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | Class 1 | 21 CFR 864.3260 | |
| MVU | Reagents, Specific, Analyte | Class 1 | 21 CFR 864.4020 | |
| MXT | Device, Accessory, Cooling Plate For Tissue Embedding Station | Class 1 | 21 CFR 864.3010 | |
| NNI | Container, Specimen, Non-Sterile | Class 1 | 21 CFR 864.3250 | |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | 21 CFR 864.3250 | |
| NNL | Container, Specimen Mailer And Storage, Temperature Controlled, Non-St | Class 1 | 21 CFR 864.3250 | |
| OHZ | Urine Transport Kit (Excludes Hiv Testing) | Class 1 | 21 CFR 864.3250 | |
| OIA | Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing | Class 1 | 21 CFR 864.3250 | |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | Class 1 | 21 CFR 864.3250 | |
| OIE | Urine Collection Kit (Excludes Hiv Testing) | Class 1 | 21 CFR 864.3250 | |
| PPM | General Purpose Reagent | Class 1 | 21 CFR 864.4010 | 16 |
| PRB | Cervical Intraepithelial Neoplasia (Cin) Test System | Class 2 | 21 CFR 864.1865 | 2 |
| PSY | Whole Slide Imaging System | Class 2 | 21 CFR 864.3700 | 23 |
| PZF | Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detec | Class 2 | 21 CFR 866.4001 | 1 |
| PZM | Next Generation Sequencing Based Tumor Profiling Test | Class 2 | 21 CFR 866.6080 | 8 |
| PZZ | Digital Pathology Display | Class 2 | 21 CFR 864.3700 | 3 |
| QDC | Dna-Based Test For Minimal Residual Disease For Hematologic Malignanci | Class 2 | 21 CFR 866.6100 | 2 |
| QDS | Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quanti | Class 2 | 21 CFR 866.4001 | 3 |
| QKQ | Digital Pathology Image Viewing And Management Software | Class 2 | 21 CFR 864.3700 | 14 |
| QPN | Software Algorithm Device To Assist Users In Digital Pathology | Class 2 | 21 CFR 864.3750 | 2 |
| QVU | High Throughput Dna Sequencing For Hereditary Cancer Predisposition As | Class 2 | 21 CFR 866.6095 | 1 |
| QYV | Digital Cervical Cytology Slide Imaging System With Artificial Intelli | Class 2 | 21 CFR 864.3900 | 1 |
| SBY | High Throughput Sequencing Based Tumor Profiling Test Of Circulating C | Class 2 | 21 CFR 866.6085 | 1 |
| SFH | Pathology Software Algorithm Device Analyzing Digital Images For Cance | Class 2 | 21 CFR 864.3755 | 1 |
| SHW | Pathology Software Algorithm Device Analyzing Digital Images For Breas | Class 2 | 21 CFR 864.3755 | 1 |
| SIX | Digital Pathology Image Artifact Detection Software Device | Class 2 | 21 CFR 864.3700 | 1 |