510(k) K800857 ยท LCP Assay, Glycosylated Hemoglobin
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
| Applicant | Helena Laboratories, Walker MI, US |
| Decision | Substantially Equivalent, Sep 26, 1980 |
| Received | Apr 15, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800857
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.