510(k) K993829 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHEK SIMPLICITY SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 9, 1999 |
| Received | Nov 12, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K993829
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.