PMA P170041
- Device
- Abbott RealTime IDH1
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170041
- Supplement
- S006
- Product code
- OWD
- Decision date
- 2026-05-28
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- implementation of manufacturing changes
Current openFDA PMA Record#
- Device
- Abbott RealTime IDH1
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170041
- Supplement
- S009
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2026-05-28
- Decision code
- OK30
- Date received
- 2026-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of manufacturing changes