Abbott RealTime IDH1 Assay
FDA premarket approval P170041/S002 · decided 2019-11-12
Approval details
- PMA number
- P170041
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Abbott RealTime IDH1 Assay
- Generic name
- Somatic gene mutation detection system
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2019-10-16
- Decision date
- 2019-11-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Update of Quality Procedures for Amplification Reagent Kit and Control Kit.
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