510(k) K131366 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Roche Diagnostics Operations, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 11, 2013 |
| Received | May 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131366
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.