510(k) K004010 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 26, 2001 |
| Received | Dec 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K004010
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.