COBAS 4800 BRAF V600 MUTATION TEST
FDA premarket approval P110020/S003 · decided 2012-09-04
Approval details
- PMA number
- P110020
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS 4800 BRAF V600 MUTATION TEST
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2011-12-12
- Decision date
- 2012-09-04
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A CHANGE IN THE DNA SYNTHESIZER INSTRUMENT PLATFORM FOR CERTAIN VIALED MASTER MIX AND PROBE REAGENT COMPONENTS.
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