COBAS 4800 BRAF V600 MUTATION TEST
FDA premarket approval P110020/S002 · decided 2011-10-26
Approval details
- PMA number
- P110020
- Supplement
- S002
- 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
- 2011-09-29
- Decision date
- 2011-10-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- CHANGES TO THE FILLING AND LABELING EQUIPMENT AND LOCATION FOR CERTAIN VIALED INTERMEDIATE COMPONENTS. YOUR FIRM HAS PROPOSED RELOCATION TO BUILDING 502 ROOMS1F24 AND 1F26 FROM BUILDING 502 ROOMS 1F23 AND 1F31 FOR USE OF NEW EQUIPMENT KUGLER LINOLINE 120 FILING AND SCREW-CAPPING LINE WHICH INCLUDES THE ACCRAPLY 4000 AND 35T LABELINGMACHINES.
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