PMA P120019S002
- Device
- COBAS EGFR MUTATION TEST
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S002
- Product code
- OWD
- Decision date
- 2013-09-06
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- CHANGE ROOMS FOR POSITIVE CONTROL FORMULATION AND FILLING.
Current openFDA PMA Record#
- Device
- COBAS EGFR MUTATION TEST
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S002
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2013-09-06
- Decision code
- OK30
- Date received
- 2013-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE ROOMS FOR POSITIVE CONTROL FORMULATION AND FILLING.