ELECSYS ANTI-HCV II IMMUNOASSAY
FDA premarket approval P140021/S002 · decided 2016-04-12
Approval details
- PMA number
- P140021
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ELECSYS ANTI-HCV II IMMUNOASSAY
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Roche Diagnostics Operations, Inc.
- Date received
- 2015-12-17
- Decision date
- 2016-04-12
- Days to decision
- 117 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 Elecsys PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the cobas e 602 analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV and is indicated for: Elecsys Anti-HCV II Immunoassay: Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human adult and pediatric (
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |