PMA P170041S004
- Device
- Abbott RealTime IDH1
- Applicant
- Abbott Molecular, Inc.
- Product code
- OWD
- Decision date
- 2022-06-02
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Approval for the labeling changes that integrate the data obtained from the non-clinical Condition of Appoval (CoA) study of eluate reproducibility.
Current openFDA PMA Record#
- Device
- Abbott RealTime IDH1
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P170041
- Supplement
- S004
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2022-06-02
- Decision code
- APPR
- Date received
- 2021-01-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the labeling changes that integrate the data obtained from the non-clinical Condition of Appoval (CoA) study of eluate reproducibility.