510(k) K080618 ยท LCP Assay, Glycosylated Hemoglobin
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
| Applicant | Jas Diagnostics, Inc., Miami FL, US |
| Decision | Substantially Equivalent, May 23, 2008 |
| Received | Mar 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080618
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.