510(k) K050872 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHEK INTEGRA SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 2, 2005 |
| Received | Apr 6, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050872
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.