510(k) K973365 ยท LCP Assay, Glycosylated Hemoglobin
AIC - CHEK (HBAIC-I)
| Applicant | Express-Med, Inc., Columbus OH, US |
| Decision | Substantially Equivalent, Jun 15, 1998 |
| Received | Sep 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973365
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.