PMA P120019S012
- Device
- cobas EGFR Mutation Test and cobas® EGFR Mutation Test, v2
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S012
- Product code
- OWD
- Decision date
- 2016-10-19
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Implementation of AQL sampling in place of 100% visual inspection for filling line.
Current openFDA PMA Record#
- Device
- cobas EGFR Mutation Test and cobas® EGFR Mutation Test, v2
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S012
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2016-10-19
- Decision code
- OK30
- Date received
- 2016-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of AQL sampling in place of 100% visual inspection for filling line.