COBAS EGFR MUTATION TEST
FDA premarket approval P120019/S006 · decided 2015-04-09
Approval details
- PMA number
- P120019
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS EGFR MUTATION TEST
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche
- Date received
- 2015-03-13
- Decision date
- 2015-04-09
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Peasanton, CA
- Statement
- CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HOMOCYSTEINE TEST (K113793) | Roche | 2012-06-05 |
| TQ HBA1C GEN3 (K102914) | Roche | 2011-01-20 |