cobas® EGFR Mutation Test, v2.0
FDA premarket approval P120019/S037 · decided 2023-12-14
Approval details
- PMA number
- P120019
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- cobas® EGFR Mutation Test, v2.0
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche
- Date received
- 2023-12-01
- Decision date
- 2023-12-14
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Peasanton, CA
- Statement
- to change the manufacturing process
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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 |