PMA P170005S004
- Device
- Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170005
- Supplement
- S004
- Product code
- OWD
- Decision date
- 2022-04-11
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Approval for addition of specifications to quality control testing.
Current openFDA PMA Record#
- Device
- Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170005
- Supplement
- S004
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2022-04-11
- Decision code
- APPR
- Date received
- 2022-03-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for addition of specifications to quality control testing.