510(k) K033674 ยท LCP Assay, Glycosylated Hemoglobin
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
| Applicant | Seradyn, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 9, 2004 |
| Received | Nov 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033674
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.