SAN
8 FDA 510(k) clearances · Product code
269 daysmedian time to decision
1026 days90th percentile
8clearances measured
FDA profile
- Official device name
- Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1650
- Medical specialty
- Microbiology
- FDA definition
- Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (K260160) | bioMerieux, Inc. | 2026-07-08 |
| PhAST instrument and PhAST Blood Culture Gram-negative Panel (K253316) | Phast Corp. | 2026-06-26 |
| ASTar BC G- Kit (K253573) | Q-Linea AB | 2026-04-15 |
| LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (K251875) | Affinity Biosensors, LLC | 2025-10-27 |
| LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (K241324) | Affinity Biosensors, LLC | 2024-10-23 |
| VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (K230675) | Specific Diagnostics, LLC | 2024-06-20 |
| ASTar BC G- Kit and ASTar Instrument (K221688) | Q-Linea AB | 2024-04-26 |
| LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (K211815) | Affinity Biosensors | 2024-04-02 |
Track SAN automatically
Every clearance here is in the API, with alerts when new ones post.