PMA P120019S008
- Device
- ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S008
- Product code
- OWD
- Decision date
- 2015-07-23
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- REMOVAL OF INCOMING ACCEPTANCE TESTING FOR TWO RAW MATERIALS.
Current openFDA PMA Record#
- Device
- ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S008
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2015-07-23
- Decision code
- OK30
- Date received
- 2015-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF INCOMING ACCEPTANCE TESTING FOR TWO RAW MATERIALS.