510(k) K142789 ยท LCP Assay, Glycosylated Hemoglobin
A1c iGear System
| Applicant | Sakae Corporation, Fujioka, Gunma, JP |
| Decision | Substantially Equivalent, Dec 16, 2014 |
| Received | Sep 26, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142789
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.