510(k) K802233 ยท LCP Assay, Glycosylated Hemoglobin
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 10, 1980 |
| Received | Sep 15, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802233
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.