| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| FMH | Container, Specimen, Sterile | 第 1 类 | 21 CFR 864.3250 | 23 |
| HZI | Acid, Osmic | 第 1 类 | 21 CFR 864.4010 | |
| IAL | Iodine (Tincture) | 第 1 类 | 21 CFR 864.4010 | |
| IAM | Solution, Lugol'S | 第 1 类 | 21 CFR 864.4010 | |
| IAT | Syrup, Gum, Apathy'S | 第 1 类 | 21 CFR 864.4010 | |
| IAW | Collodion | 第 1 类 | 21 CFR 864.4010 | |
| IAY | Colchicine | 第 1 类 | 21 CFR 864.4010 | |
| IAZ | Heparin | 第 1 类 | 21 CFR 864.4400 | |
| IBA | Streptolysin O | 第 1 类 | 21 CFR 864.4400 | |
| IBB | Phytohemaglutinin M | 第 1 类 | 21 CFR 864.4010 | |
| IBC | Diastase | 第 1 类 | 21 CFR 864.4400 | |
| IBD | Hyaluronidase | 第 1 类 | 21 CFR 864.4400 | |
| IBE | Neuramininase (Sialidase) | 第 1 类 | 21 CFR 864.4400 | |
| IBF | Papain | 第 1 类 | 21 CFR 864.4400 | |
| IBG | Trypsin | 第 1 类 | 21 CFR 864.4400 | 2 |
| IBJ | Light, Microscope | 第 1 类 | 21 CFR 864.3600 | 9 |
| IBK | Microscope, Fluorescence/U.V. | 第 1 类 | 21 CFR 864.3600 | 1 |
| IBL | Microscope, Inverted Stage, Tissue Culture | 第 1 类 | 21 CFR 864.3600 | |
| IBM | Microscope, Phase Contrast | 第 1 类 | 21 CFR 864.3600 | 1 |
| IDL | Microtome, Accessories | 第 1 类 | 21 CFR 864.3010 | 5 |
| IDM | Microtome, Ultra | 第 1 类 | 21 CFR 864.3010 | 1 |
| IDN | Microtome, Freezing Attachment | 第 1 类 | 21 CFR 864.3010 | |
| IDO | Microtome, Rotary | 第 1 类 | 21 CFR 864.3010 | 5 |
| IDP | Microtome, Cryostat | 第 1 类 | 21 CFR 864.3010 | 1 |
| IDQ | Infiltrator | 第 1 类 | 21 CFR 864.3010 | |
| IDR | Ovens, Paraffin | 第 1 类 | 21 CFR 864.3010 | |
| IDS | Melting Pot, Paraffin | 第 1 类 | 21 CFR 864.3010 | 1 |
| IDT | Apparatus, Melting Point, Paraffin | 第 1 类 | 21 CFR 864.3010 | |
| IDW | Dispensers, Paraffin | 第 1 类 | 21 CFR 864.3010 | 1 |
| IDX | Sieves, Tissue | 第 1 类 | 21 CFR 864.3010 | |
| IDY | Bath, Flotation, Tissue | 第 1 类 | 21 CFR 864.3010 | |
| IDZ | Cassettes, Tissue | 第 1 类 | 21 CFR 864.3010 | 5 |
| IEG | Table, Slide Warming | 第 1 类 | 21 CFR 864.3010 | 1 |
| IEH | Lamps, Slide Warming | 第 1 类 | 21 CFR 864.3010 | |
| IEO | Processor, Tissue, Automated | 第 1 类 | 21 CFR 864.3875 | 12 |
| IER | Polyethylene Glycol (Carbowax) | 第 1 类 | 21 CFR 864.4010 | 1 |
| IEX | Gelatin | 第 1 类 | 21 CFR 864.4010 | |
| IEZ | Celloidin | 第 1 类 | 21 CFR 864.4010 | |
| IFB | Cytocentrifuge | 第 1 类 | 21 CFR 864.3300 | 3 |
| IFF | Solution, Decalcifier, Electrolytic | 第 1 类 | 21 CFR 864.4010 | |
| IFH | Solution, Zenker'S | 第 1 类 | 21 CFR 864.4010 | 2 |
| IFI | Sprays, Synthetic, Smear | 第 1 类 | 21 CFR 864.4010 | 1 |
| IFJ | Fixative, Richardson Glycol | 第 1 类 | 21 CFR 864.4010 | |
| IFL | Polyethylene Glycol Preservative | 第 1 类 | 21 CFR 864.4010 | |
| IFN | Solution, Orth'S | 第 1 类 | 21 CFR 864.4010 | |
| IFO | Solution, Newcomer'S | 第 1 类 | 21 CFR 864.4010 | |
| IFP | Formalin, Neutral Buffered | 第 1 类 | 21 CFR 864.4010 | 15 |
| IFQ | Formulations, Mercuric Chloride For Tissue | 第 1 类 | 21 CFR 864.4010 | 2 |
| IFS | Solution, Helly | 第 1 类 | 21 CFR 864.4010 | |
| IFT | Glutaraldehyde | 第 1 类 | 21 CFR 864.4010 | 1 |
| IFY | Gelatin-Formalin | 第 1 类 | 21 CFR 864.4010 | |
| IFZ | Gelatin For Specimen Adhesion | 第 1 类 | 21 CFR 864.4010 | 1 |
| IGB | Solution, Formalin-Sodium Acetate | 第 1 类 | 21 CFR 864.4010 | 1 |
| IGC | Formalin-Saline | 第 1 类 | 21 CFR 864.4010 | 2 |
| IGD | Solution, Formol Calcium | 第 1 类 | 21 CFR 864.4010 | |
| IGE | Solution, Formalin Ammonium Bromide | 第 1 类 | 21 CFR 864.4010 | 2 |
| IGF | Solution, Formalin-Alcohol-Acetic Acid | 第 1 类 | 21 CFR 864.4010 | 1 |
| IGG | Formaldehyde (Formalin, Formol) | 第 1 类 | 21 CFR 864.4010 | 7 |
| IGK | Solution, Clarke'S | 第 1 类 | 21 CFR 864.4010 | |
| IGM | Solution, Carnoy'S | 第 1 类 | 21 CFR 864.4010 | 3 |
| IGN | Fluid, Bouin'S | 第 1 类 | 21 CFR 864.4010 | 2 |
| IHJ | Blender, Sputum | 第 1 类 | 21 CFR 864.3010 | |
| IJZ | Oil, Clearing | 第 1 类 | 21 CFR 864.4010 | 1 |
| JCB | Detergent | 第 1 类 | 21 CFR 864.4010 | |
| JCC | Ph Buffer | 第 1 类 | 21 CFR 864.4010 | 7 |
| JCE | Solution, Isotonic | 第 1 类 | 21 CFR 864.4010 | 7 |
| KDT | Container, Specimen Mailer And Storage, Sterile | 第 1 类 | 21 CFR 864.3250 | 12 |
| KDW | Container, Specimen Mailer And Storage, Temperature Controlled, Steril | 第 1 类 | 21 CFR 864.3250 | 4 |
| KDX | Solution, Decalcifier, Acid Containing | 第 1 类 | 21 CFR 864.4010 | 8 |
| KDY | Agent, Chelating For Decalcification | 第 1 类 | 21 CFR 864.4010 | |
| KDZ | Device, Decalcifier, Electrolytic | 第 1 类 | 21 CFR 864.3010 | |
| KEE | Osmium Tetroxide | 第 1 类 | 21 CFR 864.4010 | |
| KEF | Paraformaldehyde | 第 1 类 | 21 CFR 864.4010 | |
| KEG | Lamps, Microscope | 第 1 类 | 21 CFR 864.3600 | |
| KEH | Micrometers, Microscope | 第 1 类 | 21 CFR 864.3600 | |
| KEI | Condensers, Microscope | 第 1 类 | 21 CFR 864.3600 | |
| KEJ | Stages, Microscope | 第 1 类 | 21 CFR 864.3600 | 1 |
| KEL | Adhesive, Albumin-Based | 第 1 类 | 21 CFR 864.4010 | 2 |
| KEM | Agent, Clearing | 第 1 类 | 21 CFR 864.4010 | 15 |
| KEO | Formulations, Paraffin, All | 第 1 类 | 21 CFR 864.4010 | 11 |
| KEP | Media, Mounting, Oil Soluble | 第 1 类 | 21 CFR 864.4010 | 3 |
| KEQ | Media, Mounting, Water Soluble | 第 1 类 | 21 CFR 864.4010 | 7 |
| KER | Container, Embedding | 第 1 类 | 21 CFR 864.3010 | 5 |
| KES | Coverslips, Microscope Slide | 第 1 类 | 21 CFR 864.3010 | 3 |
| KET | Filters, Cell Collection, Tissue Processing | 第 1 类 | 21 CFR 864.3010 | 5 |
| KEW | Slides, Microscope | 第 1 类 | 21 CFR 864.3010 | 8 |
| KEY | Stainer, Tissue, Automated | 第 1 类 | 21 CFR 864.3800 | 1 |
| KFL | Microtome, Sliding | 第 1 类 | 21 CFR 864.3010 | |
| KIM | Device For Sealing Microsections | 第 1 类 | 21 CFR 864.3400 | 1 |
| KIN | Slide Stainer, Contact Type | 第 1 类 | 21 CFR 864.3800 | 1 |
| KIO | Slide Stainer, Immersion Type | 第 1 类 | 21 CFR 864.3800 | 1 |
| KJG | Tube, Tissue Culture | 第 1 类 | 21 CFR 864.3010 | 1 |
| KPA | Slide Stainer, Automated | 第 1 类 | 21 CFR 864.3800 | 21 |
| LDW | Fixative, Acid Containing | 第 1 类 | 21 CFR 864.4010 | 4 |
| LDX | Fixative, Metallic Containing | 第 1 类 | 21 CFR 864.4010 | 1 |
| LDY | Fixative, Formalin-Containing | 第 1 类 | 21 CFR 864.4010 | 1 |
| LDZ | Fixative, Alcohol Containing | 第 1 类 | 21 CFR 864.4010 | 8 |
| LEA | Preservative, Cytological | 第 1 类 | 21 CFR 864.4010 | 4 |
| LEB | Mounting Media | 第 1 类 | 21 CFR 864.4010 | 5 |
| LEC | Grinder, Tissue | 第 1 类 | 21 CFR 864.3010 | |
| LIJ | Peroxidase Anti-Peroxidase Immunohistochemical Stain | 第 1 类 | 21 CFR 864.4400 | 2 |
| MJI | Specimen/Tissue, Identification Orientation | 第 1 类 | 21 CFR 864.3010 | |
| MPQ | Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | 第 1 类 | 21 CFR 864.3260 | |
| MVU | Reagents, Specific, Analyte | 第 1 类 | 21 CFR 864.4020 | |
| MXT | Device, Accessory, Cooling Plate For Tissue Embedding Station | 第 1 类 | 21 CFR 864.3010 | |
| NNI | Container, Specimen, Non-Sterile | 第 1 类 | 21 CFR 864.3250 | |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | 第 1 类 | 21 CFR 864.3250 | |
| NNL | Container, Specimen Mailer And Storage, Temperature Controlled, Non-St | 第 1 类 | 21 CFR 864.3250 | |
| OHZ | Urine Transport Kit (Excludes Hiv Testing) | 第 1 类 | 21 CFR 864.3250 | |
| OIA | Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing | 第 1 类 | 21 CFR 864.3250 | |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 第 1 类 | 21 CFR 864.3250 | |
| OIE | Urine Collection Kit (Excludes Hiv Testing) | 第 1 类 | 21 CFR 864.3250 | |
| PPM | General Purpose Reagent | 第 1 类 | 21 CFR 864.4010 | 16 |
| PRB | Cervical Intraepithelial Neoplasia (Cin) Test System | 第 2 类 | 21 CFR 864.1865 | 2 |
| PSY | Whole Slide Imaging System | 第 2 类 | 21 CFR 864.3700 | 23 |
| PZF | Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detec | 第 2 类 | 21 CFR 866.4001 | 1 |
| PZM | Next Generation Sequencing Based Tumor Profiling Test | 第 2 类 | 21 CFR 866.6080 | 8 |
| PZZ | Digital Pathology Display | 第 2 类 | 21 CFR 864.3700 | 3 |
| QDC | Dna-Based Test For Minimal Residual Disease For Hematologic Malignanci | 第 2 类 | 21 CFR 866.6100 | 2 |
| QDS | Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quanti | 第 2 类 | 21 CFR 866.4001 | 3 |
| QKQ | Digital Pathology Image Viewing And Management Software | 第 2 类 | 21 CFR 864.3700 | 14 |
| QPN | Software Algorithm Device To Assist Users In Digital Pathology | 第 2 类 | 21 CFR 864.3750 | 2 |
| QVU | High Throughput Dna Sequencing For Hereditary Cancer Predisposition As | 第 2 类 | 21 CFR 866.6095 | 1 |
| QYV | Digital Cervical Cytology Slide Imaging System With Artificial Intelli | 第 2 类 | 21 CFR 864.3900 | 1 |
| SBY | High Throughput Sequencing Based Tumor Profiling Test Of Circulating C | 第 2 类 | 21 CFR 866.6085 | 1 |
| SFH | Pathology Software Algorithm Device Analyzing Digital Images For Cance | 第 2 类 | 21 CFR 864.3755 | 1 |
| SHW | Pathology Software Algorithm Device Analyzing Digital Images For Breas | 第 2 类 | 21 CFR 864.3755 | 1 |
| SIX | Digital Pathology Image Artifact Detection Software Device | 第 2 类 | 21 CFR 864.3700 | 1 |