510(k) K082275 ยท LCP Assay, Glycosylated Hemoglobin
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
| Applicant | Infopia Co, Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Jan 14, 2010 |
| Received | Aug 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082275
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.