THxID BRAF assay kit
FDA premarket approval P120014/S009 · decided 2019-08-26
Approval details
- PMA number
- P120014
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THxID BRAF assay kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- bioMerieux, Inc.
- Date received
- 2019-08-07
- Decision date
- 2019-08-26
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- Manufacturing site change for a raw material (critical component).
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