510(k) K173127 ยท LCP Assay, Glycosylated Hemoglobin
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
| Applicant | Skyla Corporation H.S.P.B, Hsinchu City, TW |
| Decision | Substantially Equivalent, Sep 25, 2018 |
| Received | Sep 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173127
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.