PMA P120014S011
- Device
- THxID-BRAF kit
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S011
- Product code
- OWD
- Decision date
- 2021-03-10
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Qualification of rooms to support manufacturing activities.
Current openFDA PMA Record#
- Device
- THxID-BRAF kit
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S011
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2021-03-10
- Decision code
- OK30
- Date received
- 2021-02-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of rooms to support manufacturing activities.