Panels › Microbiology › Product code SAN · Class 2
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Regulation 866.1650
3510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SAN
| Company | 510(k)s | Recalls |
|---|---|---|
| Affinity Biosensors | 3 | 0 |
| Q-Linea AB | 2 | 0 |
| bioMerieux, Inc. | 1 | 0 |
| Phast Corp. | 1 | 0 |
| Specific Diagnostics, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2026 | K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System bioMerieux, Inc. | SAN |
| Jun 26, 2026 | K253316 | PhAST instrument and PhAST Blood Culture Gram-negative Panel Phast Corp. | SAN |
| Apr 15, 2026 | K253573 | ASTar BC G- Kit Q-Linea AB, SE | SAN |
| Oct 27, 2025 | K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system Affinity Biosensors, LLC | SAN |
| Oct 23, 2024 | K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system Affinity Biosensors, LLC | SAN |
| Jun 20, 2024 | K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System Specific Diagnostics, LLC | SAN |
| Apr 26, 2024 | K221688 | ASTar BC G- Kit and ASTar Instrument Q-Linea AB, SE | SAN |
| Apr 2, 2024 | K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System Affinity Biosensors | SAN |
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