ACCU-CHEK AVIVA PLUS SYSTEM
FDA 510(k) clearance K133862 · decided 2014-04-29
Clearance details
- K-number
- K133862
- Device name
- ACCU-CHEK AVIVA PLUS SYSTEM
- Applicant
- Roche Diagnostics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2013-12-19
- Decision date
- 2014-04-29
- Days to decision
- 131 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 II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monito recall (Z-2765-2019) | Roche Diabetes Care, Inc. | 2019-09-30 |
| Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Mon recall (Z-2766-2019) | Roche Diabetes Care, Inc. | 2019-09-30 |