PMA P120014S009
- Device
- THxID BRAF assay kit
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S009
- Product code
- OWD
- Decision date
- 2019-08-26
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Manufacturing site change for a raw material (critical component).
Current openFDA PMA Record#
- Device
- THxID BRAF assay kit
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S009
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2019-08-26
- Decision code
- OK30
- Date received
- 2019-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing site change for a raw material (critical component).