THXID BRAF KIT
FDA premarket approval P120014/S005 · decided 2015-06-05
Approval details
- PMA number
- P120014
- Supplement
- S005
- 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
- 2015-05-08
- Decision date
- 2015-06-05
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- CHANGE IN THE METHOD USED TO DETERMINE THE CONCENTRATION OF THE OLIGONUCLEOTIDES AND PROBES USED IN THE TEST KIT.
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