COBAS 4800 BRAF V600 MUTATION TEST
FDA premarket approval P110020/S004 · decided 2012-11-19
Approval details
- PMA number
- P110020
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBAS 4800 BRAF V600 MUTATION TEST
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2012-07-02
- Decision date
- 2012-11-19
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR CHANGES TO THE CPU COMPONENT OF THE COBAS Z480 ANALYZER.
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