510(k) K051592 ยท LFR Glucose Dehydrogenase, Glucose
MODIFICATION TO ACCU-CHEK GO SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 2, 2005 |
| Received | Jun 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051592
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.