PMA P120019S042
- Device
- cobas® EGFR Mutation Test, v2.0
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S042
- Product code
- OWD
- Decision date
- 2025-12-31
- Classification
- Pathology
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- changes to QC testing of filters used in reagent manufacturing
Current openFDA PMA Record#
- Device
- cobas® EGFR Mutation Test, v2.0
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S042
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2025-12-31
- Decision code
- OK30
- Date received
- 2025-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to QC testing of filters used in reagent manufacturing