PMA P120019S017
- Device
- Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S017
- Product code
- OWD
- Decision date
- 2017-11-13
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Scale-up production of a bulk reagent.
Current openFDA PMA Record#
- Device
- Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S017
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2017-11-13
- Decision code
- OK30
- Date received
- 2017-10-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Scale-up production of a bulk reagent.