ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190
FDA premarket approval P110020/S006 · decided 2013-01-10
Approval details
- PMA number
- P110020
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2012-09-12
- Decision date
- 2013-01-10
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE ADDITION OF POLY RA TO THE BRAF MUTANT AND WILD-TYPE CONTROLS BUFFER MATRIX AND ASSOCIATED MANUFACTURING PROCESS CHANGES.
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