VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
FDA 510(k) clearance K230675 · decided 2024-06-20
Clearance details
- K-number
- K230675
- Device name
- VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- Applicant
- Specific Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-03-10
- Decision date
- 2024-06-20
- Days to decision
- 468 days
- Clearance type
- Traditional
- Product code
- SAN
- Device class
- 2
- Regulation number
- 866.1650
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.