510(k) K133741 ยท NBW System, Test, Blood Glucose, Over The Counter
ACCU-CHEK Performa Blood Glucose Monitoring System
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 29, 2014 |
| Received | Dec 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133741
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2021 | Roche Diabetes Care, Inc. Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001 Open, Classified |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.