510(k) K921305 ยท LCP Assay, Glycosylated Hemoglobin
GLYCO-TEK AFFINITY COLUMN KIT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jun 9, 1992 |
| Received | Mar 12, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921305
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.