PMA P120019S027
- Device
- cobas EGFR Mutation Test v2
- Applicant
- Roche
- Product code
- OWD
- Decision date
- 2025-01-27
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Approval for cobas' EGFR Mutation Test v2 label to include Roche Cell-free DNA Collection Tube as an alternative blood collection tube.
Current openFDA PMA Record#
- Device
- cobas EGFR Mutation Test v2
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S027
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2025-01-27
- Decision code
- APPR
- Date received
- 2019-03-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for cobas' EGFR Mutation Test v2 label to include Roche Cell-free DNA Collection Tube as an alternative blood collection tube.