510(k) K893224 ยท LCP Assay, Glycosylated Hemoglobin
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jun 20, 1989 |
| Received | Apr 27, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893224
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.