PMA P120019S029
- Device
- cobas EGFR Mutation Test v2
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S029
- Product code
- OWD
- Decision date
- 2019-09-25
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Approval for a formulation change to the cobas® DNA Sample Preparation Kit used with the cobas® EGFR Mutation Test for plasma and tissues specimens.
Current openFDA PMA Record#
- Device
- cobas EGFR Mutation Test v2
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S029
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2019-09-25
- Decision code
- APPR
- Date received
- 2019-06-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a formulation change to the cobas® DNA Sample Preparation Kit used with the cobas® EGFR Mutation Test for plasma and tissues specimens.