THXID-BRAF
FDA premarket approval P120014/S012 · decided 2021-12-20
Approval details
- PMA number
- P120014
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THXID-BRAF
- Generic name
- Somatic gene mutation detection system
- Applicant
- bioMerieux, Inc.
- Date received
- 2021-11-23
- Decision date
- 2021-12-20
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- Transfer of manufacturing site location for a critical component.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (K260160) | bioMerieux, Inc. | 2026-07-08 |
| VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (K260282) | bioMerieux, Inc. | 2026-04-15 |
| VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579) | bioMerieux, Inc. | 2025-08-21 |
| VITEK COMPACT PRO (K234012) | bioMerieux, Inc. | 2025-03-14 |
| VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (K232967) | bioMerieux, Inc. | 2024-06-12 |
| VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (K232963) | bioMerieux, Inc. | 2024-06-07 |
| VIDAS TBI (GFAP, UCH-L1) (K240279) | bioMerieux, Inc. | 2024-05-01 |
| VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (K234000) | bioMerieux, Inc. | 2024-03-11 |