COBAS BRAF V600 MUTATION TEST
FDA premarket approval P110020/S010 · decided 2014-03-12
Approval details
- PMA number
- P110020
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBAS BRAF V600 MUTATION TEST
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2013-12-13
- Decision date
- 2014-03-12
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR CHANGES TO THE COBAS® 4800 SR2 SYSTEM SOFTWARE ARCHITECTURE AND ASSAY SPECIFIC ANALYSIS PACKAGE (ASAP) SOFTWARE FOR THE COBAS® BRAF V600 MUTATION TEST AND COBAS® EGFR MUTATION TEST.
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