SAN
- Product code
- SAN
- Device name
- Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.1650
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 8 (all years; only the last 3 years are listed here)
FDA classification definition
Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260160 | 2026-07-08 | bioMerieux, Inc. | VITEK REVEAL GN AST Assay and VITEK REVEAL AST Syste… | |
| K253316 | 2026-06-26 | Phast Corp. | PhAST instrument and PhAST Blood Culture Gram-negati… | FDA |
| K253573 | 2026-04-15 | Q-Linea AB | ASTar BC G- Kit | |
| K251875 | 2025-10-27 | Affinity Biosensors, LLC | LifeScale Gram Negative Kit (LSGN) with the LifeScal… | |
| K241324 | 2024-10-23 | Affinity Biosensors, LLC | LifeScale Gram Negative Kit (LSGN) with the LifeScal… | |
| K230675 | 2024-06-20 | Specific Diagnostics, LLC | VITEK REVEAL GN AST Assay and VITEK REVEAL AST Syste… | |
| K221688 | 2024-04-26 | Q-Linea AB | ASTar BC G- Kit and ASTar Instrument | |
| K211815 | 2024-04-02 | Affinity Biosensors | LifeScale Gram Negative Kit (LSGN) with the LifeScal… |
Official FDA classification page: SAN
Classification and pathway per current FDA publications. Data from openFDA (CC0).