510(k) K133862 ยท NBW System, Test, Blood Glucose, Over The Counter
ACCU-CHEK AVIVA PLUS SYSTEM
| Applicant | Roche Diagnostics Corporation, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 29, 2014 |
| Received | Dec 19, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2019 | Roche Diabetes Care, Inc. Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whol Terminated |
NBW | None listed |
| Sep 30, 2019 | Roche Diabetes Care, Inc. Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary w Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.