510(k) K790046 ยท LCP Assay, Glycosylated Hemoglobin
G-HB QUIK COLUMN CONTROL
| Applicant | Helena Laboratories, Walker MI, US |
| Decision | Substantially Equivalent, Jan 26, 1979 |
| Received | Jan 5, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K790046
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.