THXID BRAF KIT
FDA premarket approval P120014/S003 · decided 2015-05-27
Approval details
- PMA number
- P120014
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THXID BRAF KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- bioMerieux, Inc.
- Date received
- 2015-02-24
- Decision date
- 2015-05-27
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- APPROVAL FOR USING THE UPDATED ABI 7500 FAST DX OPERATING SYSTEM AND SDS SOFTWARE.
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