PMA P140023S025
- Device
- cobas® KRAS Mutation Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P140023
- Supplement
- S025
- Product code
- OWD
- Decision date
- 2022-11-14
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Removal of an in-process testing (IPT) from the manufacturing process.
Current openFDA PMA Record#
- Device
- cobas® KRAS Mutation Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P140023
- Supplement
- S025
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2022-11-14
- Decision code
- OK30
- Date received
- 2022-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of an in-process testing (IPT) from the manufacturing process.