510(k) K121679 ยท NBW System, Test, Blood Glucose, Over The Counter
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 11, 2012 |
| Received | Jun 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121679
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2021 | Roche Diabetes Care, Inc. Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001 Open, Classified |
NBW | None listed |
| Mar 14, 2016 | Roche Diagnostics Operations, Inc. Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System
Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitr Terminated |
LFR | None listed |
| Apr 15, 2013 | Roche Diagnostics Operations, Inc. ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner.
Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar). Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.