510(k) K042193 ยท LCP Assay, Glycosylated Hemoglobin
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
| Applicant | Diazyme Laboratories, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 29, 2004 |
| Received | Aug 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042193
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.