COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0
FDA premarket approval P000012/S003 · decided 2004-08-30
Approval details
- PMA number
- P000012
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2004-02-13
- Decision date
- 2004-08-30
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE COBAS AMPLIPREP/ COBAS AMPLICOR HCV TEST, V2.0 INSTRUMENT WHICH FULLY AUTOMATES THE SPECIMEN TESTING PORTION OF THE TEST.
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510(k) clearances by this applicant
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|---|---|---|
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