510(k) K032076 ยท LFR Glucose Dehydrogenase, Glucose
SENOVA(R) BLOOD GLUCOSE MONITOR
| Applicant | Chdiagnostics, LLC, Rockville MD, US |
| Decision | Substantially Equivalent, Sep 30, 2003 |
| Received | Jul 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2005 | CHdiagnostics SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.