Cobas EGFR MUTATION TEST v2
FDA premarket approval P150047/S002 · decided 2016-10-19
Approval details
- PMA number
- P150047
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cobas EGFR MUTATION TEST v2
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2016-09-22
- Decision date
- 2016-10-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Implementation of AQL sampling in place of 100% visual inspection for filling line.
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510(k) clearances by this applicant
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|---|---|---|
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
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