PMA P170005S003
- Device
- Abbott RealTime IDH2
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170005
- Supplement
- S003
- Product code
- OWD
- Decision date
- 2021-03-03
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Addition of alternative testing location for a device component.
Current openFDA PMA Record#
- Device
- Abbott RealTime IDH2
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170005
- Supplement
- S003
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2021-03-03
- Decision code
- OK30
- Date received
- 2021-02-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternative testing location for a device component.