PMA P140023S022
- Device
- cobas KRAS Mutation Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P140023
- Supplement
- S022
- Product code
- OWD
- Decision date
- 2020-05-18
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Approval for a formulation change to the cobas DNA Sample Preparation Kit used with the cobas KRAS Mutation Test (P140023).
Current openFDA PMA Record#
- Device
- cobas KRAS Mutation Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P140023
- Supplement
- S022
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2020-05-18
- Decision code
- APPR
- Date received
- 2020-02-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a formulation change to the cobas DNA Sample Preparation Kit used with the cobas KRAS Mutation Test (P140023).