ROCHE COBAS 4800 BRAF V600 MUTATION TEST
FDA premarket approval P110020/S001 · decided 2011-10-17
Approval details
- PMA number
- P110020
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ROCHE COBAS 4800 BRAF V600 MUTATION TEST
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2011-09-19
- Decision date
- 2011-10-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- ADDITIONAL OF FUNCTIONAL TESTING AT THE FINAL VIAL STAGE IN THE MANUFACTURE OF THE DEVICE MUTATION POSITIVE CONTROL (MU) AND THE WILD-TYPE CONTROL (WT).
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