PMA P120019S021
- Device
- Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S021
- Product code
- OWD
- Decision date
- 2018-07-03
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Reduce Environmental Monitoring testing at a manufacturing facility.
Current openFDA PMA Record#
- Device
- Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S021
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2018-07-03
- Decision code
- OK30
- Date received
- 2018-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce Environmental Monitoring testing at a manufacturing facility.