PMA P170005S005
- Device
- Abbott RealTime IDH2
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170005
- Supplement
- S005
- Product code
- OWD
- Decision date
- 2026-03-20
- Classification
- Medical Genetics
- Generic name
- Somatic gene mutation detection system
Current openFDA PMA Record#
- Device
- Abbott RealTime IDH2
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170005
- Supplement
- S005
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2026-03-20
- Decision code
- OK30
- Date received
- 2026-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier