510(k) K963844 ยท LCP Assay, Glycosylated Hemoglobin
HYDRAGEL 15 HB A1C KIT
| Applicant | Morax, Chelsea MI, US |
| Decision | Substantially Equivalent, Apr 22, 1997 |
| Received | Sep 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963844
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.