PMA P170041S002
- Device
- Abbott RealTime IDH1 Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170041
- Supplement
- S002
- Product code
- OWD
- Decision date
- 2019-11-12
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Update of Quality Procedures for Amplification Reagent Kit and Control Kit.
Current openFDA PMA Record#
- Device
- Abbott RealTime IDH1 Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170041
- Supplement
- S002
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2019-11-12
- Decision code
- OK30
- Date received
- 2019-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update of Quality Procedures for Amplification Reagent Kit and Control Kit.