510(k) K131029 ยท NBW System, Test, Blood Glucose, Over The Counter
ACCU-CHEK AVIVA PLUS TEST STRIP
| Applicant | Roche Diagnostics Operations, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 9, 2013 |
| Received | Apr 12, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131029
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2021 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001 Open, Classified |
LZG | None listed |
| Dec 11, 2019 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System
Catalog Number: 06908349001 Terminated |
NBW | None listed |
| Dec 11, 2019 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System
Catalog Number: 06908217001 Terminated |
NBW | None listed |
| May 9, 2018 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001
Product Usage:
The Accu-Chek Aviva Plus test strips are for use with t Terminated |
LFR | None listed |
| May 9, 2018 | Roche Diabetes Care, Inc. Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001
Product Usage:
The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitative Terminated |
LFR | None listed |
| May 9, 2018 | Roche Diabetes Care, Inc. Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001
Product Usage:
The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitat Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.