510(k) K160762 ยท LCP Assay, Glycosylated Hemoglobin
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Nov 21, 2016 |
| Received | Mar 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160762
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.