PMA P120019S022
- Device
- cobas EGFR Mutation Test, V2.0
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S022
- Product code
- OWD
- Decision date
- 2018-07-05
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Eliminate a duplicative in-process test for designated kit reagents.
Current openFDA PMA Record#
- Device
- cobas EGFR Mutation Test, V2.0
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S022
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2018-07-05
- Decision code
- OK30
- Date received
- 2018-06-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Eliminate a duplicative in-process test for designated kit reagents.