PMA P120014S007
- Device
- THxID-BRAF kit
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S007
- Product code
- OWD
- Decision date
- 2016-11-22
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Change of plastic resin used to manufacture the elution tube.
Current openFDA PMA Record#
- Device
- THxID-BRAF kit
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S007
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2016-11-22
- Decision code
- OK30
- Date received
- 2016-10-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of plastic resin used to manufacture the elution tube.