FDA Product Code
FDA Product Code SAN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.1650
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | 2026-07-08 | Traditional | PDF ↗ |
| K253316 | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | 2026-06-26 | Traditional | PDF ↗ |
| K253573 | ASTar BC G- Kit | Q-Linea AB | 2026-04-15 | Traditional | PDF ↗ |
| K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | 2025-10-27 | Traditional | PDF ↗ |
| K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | 2024-10-23 | Traditional | PDF ↗ |
| K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | Specific Diagnostics, LLC | 2024-06-20 | Traditional | PDF ↗ |
| K221688 | ASTar BC G- Kit and ASTar Instrument | Q-Linea AB | 2024-04-26 | Traditional | PDF ↗ |
| K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | Affinity Biosensors | 2024-04-02 | Traditional | PDF ↗ |
Product code SAN · Class II · Microbiology. Data: openFDA.