PMA P120019S043
- Device
- cobas® EGFR Mutation Test, v2.0
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S043
- Product code
- OWD
- Decision date
- 2026-03-17
- Classification
- Pathology
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- to revise QC methods for supplied materials
Current openFDA PMA Record#
- Device
- cobas® EGFR Mutation Test, v2.0
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S043
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2026-03-17
- Decision code
- OK30
- Date received
- 2026-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to revise QC methods for supplied materials