Elecsys Anti-HCV II, PreciControl Anti-HCV
FDA premarket approval P140021/S010 · decided 2017-11-03
Approval details
- PMA number
- P140021
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Elecsys Anti-HCV II, PreciControl Anti-HCV
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Roche Diagnostics Operations, Inc.
- Date received
- 2017-07-03
- Decision date
- 2017-11-03
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the cobas e 801 immunoassay analyzer.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (K131366) | Roche Diagnostics Operations, Inc. | 2013-10-11 |
| ACCU-CHEK AVIVA PLUS TEST STRIP (K131029) | Roche Diagnostics Operations, Inc. | 2013-08-09 |