PMA P120019S028
- Device
- COBAS EGFR Mutation Test and cobas EGFR Mutation Test, v2.0
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S028
- Product code
- OWD
- Decision date
- 2019-05-22
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Changes in manufacturing gowning procedures.
Current openFDA PMA Record#
- Device
- COBAS EGFR Mutation Test and cobas EGFR Mutation Test, v2.0
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S028
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2019-05-22
- Decision code
- OK30
- Date received
- 2019-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes in manufacturing gowning procedures.