PMA P120019S006
- Device
- COBAS EGFR MUTATION TEST
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S006
- Product code
- OWD
- Decision date
- 2015-04-09
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.
Current openFDA PMA Record#
- Device
- COBAS EGFR MUTATION TEST
- Applicant
- Roche
- PMA number
- P120019
- Supplement
- S006
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2015-04-09
- Decision code
- OK30
- Date received
- 2015-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.