ACCU-CHEK AVIVA PLUS TEST STRIP
FDA 510(k) clearance K131029 · decided 2013-08-09
Clearance details
- K-number
- K131029
- Device name
- ACCU-CHEK AVIVA PLUS TEST STRIP
- Applicant
- Roche Diagnostics Operations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-12
- Decision date
- 2013-08-09
- Days to decision
- 119 days
- Clearance type
- Special
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001 recall (Z-2185-2018) | Roche Diabetes Care, Inc. | 2018-05-09 |
| Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Pr recall (Z-2186-2018) | Roche Diabetes Care, Inc. | 2018-05-09 |
| Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 P recall (Z-2187-2018) | Roche Diabetes Care, Inc. | 2018-05-09 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys HBeAg (P130015/S022) | Roche Diagnostics Operations, Inc. | 2025-05-22 |
| Elecsys HBeAg (P130015/S021) | Roche Diagnostics Operations, Inc. | 2024-10-03 |
| Elecsys HBeAg (P130015/S020) | Roche Diagnostics Operations, Inc. | 2024-08-29 |
| Elecsys HBeAg (P130015/S019) | Roche Diagnostics Operations, Inc. | 2024-02-08 |
| Elecsys HBeAg (P130015/S018) | Roche Diagnostics Operations, Inc. | 2023-10-31 |
| Elecsys HBeAg Test System (P130015/S017) | Roche Diagnostics Operations, Inc. | 2023-04-18 |
| Elecsys Anti-HCV II (P140021/S016) | Roche Diagnostics Operations, Inc. | 2019-04-24 |
| Elecsys HBeAg (P130015/S016) | Roche Diagnostics Operations, Inc. | 2018-11-06 |