ABBOTT REALTIME HCV GENOTYPE II
FDA premarket approval P120012/S010 · decided 2016-03-07
Approval details
- PMA number
- P120012
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT REALTIME HCV GENOTYPE II
- Generic name
- Assay, genotyping, hepatitis c virus
- Applicant
- Abbott Molecular
- Date received
- 2015-12-16
- Decision date
- 2016-03-07
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- OBF
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Approval for revisions to the application specification file for changes to the liquid level sense and pipette aspiration/dispense volumes during the sample preparation extraction process.
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