PMA P120019S032
- Device
- cobas EGFR Mutation Test and cobas EGFR Mutation Test v2
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S032
- Product code
- OWD
- Decision date
- 2020-08-26
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Manufacturing process change to use an alternate filter.
Current openFDA PMA Record#
- Device
- cobas EGFR Mutation Test and cobas EGFR Mutation Test v2
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S032
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2020-08-26
- Decision code
- OK30
- Date received
- 2020-07-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process change to use an alternate filter.