510(k) K130014 ยท LCP Assay, Glycosylated Hemoglobin
A1C GEAR SYSTEM
| Applicant | Sakae Corporation, Los Angeles CA, US |
| Decision | Substantially Equivalent, Apr 4, 2014 |
| Received | Jan 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130014
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.