Elecsys ANti-HCV II (100/200 tests)
FDA premarket approval P140021/S015 · decided 2018-11-06
Approval details
- PMA number
- P140021
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Elecsys ANti-HCV II (100/200 tests)
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Roche Diagnostics Operations, Inc.
- Date received
- 2018-10-09
- Decision date
- 2018-11-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Addition of a secondary manufacturer/supplier of a component raw material.
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 |