PMA P170005S001
- Device
- RealTime IDH2
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170005
- Supplement
- S001
- Product code
- OWD
- Decision date
- 2019-09-24
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Additional internal QC testing for the DNA Sample Preparation Kit.
Current openFDA PMA Record#
- Device
- RealTime IDH2
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170005
- Supplement
- S001
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2019-09-24
- Decision code
- OK30
- Date received
- 2019-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional internal QC testing for the DNA Sample Preparation Kit.