510(k) K791365 ยท LCP Assay, Glycosylated Hemoglobin
FAST FLOW #60310
| Applicant | Hi Chem, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 27, 1979 |
| Received | Jul 25, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K791365
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.