510(k) K904814 ยท LCP Assay, Glycosylated Hemoglobin
GLYC-AFFIN GP
| Applicant | Isolab, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Dec 26, 1990 |
| Received | Oct 24, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904814
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.