510(k) K113137 ยท NBW System, Test, Blood Glucose, Over The Counter
GLUCOSE TEST SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 6, 2012 |
| Received | Oct 24, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2021 | Roche Diabetes Care, Inc. Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001 Open, Classified |
LFR | None listed |
| Mar 16, 2021 | Cardinal Health Inc. ACCU-CHEK SMARTVIEW 100 TEST STRIPS
Item Number: 4742862 Open, Classified |
NBW | None listed |
| Apr 9, 2012 | Roche Diagnostics Operations, Inc. ACCU-CHEK Aviva Nano Blood Glucose Meter
No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representa Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.