510(k) K100547 ยท LCP Assay, Glycosylated Hemoglobin
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
| Applicant | Seppim S.A.S., Bothell WA, US |
| Decision | Substantially Equivalent, May 19, 2011 |
| Received | Feb 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100547
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.