COBAS 4800 BRAF V600 MUTATION TEST
FDA premarket approval P110020/S012 · decided 2015-01-15
Approval details
- PMA number
- P110020
- Supplement
- S012
- Supplement type
- 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
- 2014-12-19
- Decision date
- 2015-01-15
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- CHANGE TO THE HPLC SYSTEM QUALIFICATION RETENTION TIME WINDOW FOR THE PURIFICATION OF AN OLIGONUCLEOTIDE.
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