PMA P120014S003
- Device
- THXID BRAF KIT
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S003
- Product code
- OWD
- Decision date
- 2015-05-27
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- APPROVAL FOR USING THE UPDATED ABI 7500 FAST DX OPERATING SYSTEM AND SDS SOFTWARE.
Current openFDA PMA Record#
- Device
- THXID BRAF KIT
- Applicant
- bioMerieux, Inc.
- PMA number
- P120014
- Supplement
- S003
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2015-05-27
- Decision code
- APPR
- Date received
- 2015-02-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR USING THE UPDATED ABI 7500 FAST DX OPERATING SYSTEM AND SDS SOFTWARE.