PMA P120014
- Device
- THXID™-BRAF
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S012
- Product code
- OWD
- Decision date
- 2021-12-20
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Transfer of manufacturing site location for a critical component.
Current openFDA PMA Record#
- Device
- THXID™-BRAF
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S012
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2021-12-20
- Decision code
- OK30
- Date received
- 2021-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of manufacturing site location for a critical component.