510(k) K133803 ยท LCP Assay, Glycosylated Hemoglobin
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Aug 6, 2014 |
| Received | Dec 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133803
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.