Elecsys Anti-HCV II
FDA premarket approval P140021/S016 · decided 2019-04-24
Approval details
- PMA number
- P140021
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Elecsys Anti-HCV II
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Roche Diagnostics Operations, Inc.
- Date received
- 2018-10-26
- Decision date
- 2019-04-24
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for a manufacturing site for the cobas e 411 Analyzer located at Hitachi High-Technologies Corp., 1892-1, Oazategama, Omuta, Fukuoka, 836-0004 Japan
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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 |