510(k) K842689 ยท LCP Assay, Glycosylated Hemoglobin
GLYCO-TEK AFFINITY COLUMN
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 15, 1984 |
| Received | Jul 10, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842689
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.