THxID-BRAF kit
FDA premarket approval P120014/S011 · decided 2021-03-10
Approval details
- PMA number
- P120014
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THxID-BRAF kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- bioMerieux, Inc.
- Date received
- 2021-02-12
- Decision date
- 2021-03-10
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- Qualification of rooms to support manufacturing activities.
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