510(k) K905513 ยท LCP Assay, Glycosylated Hemoglobin
GLYC-AFFIN(TM)-GA
| Applicant | Isolab, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Jan 15, 1991 |
| Received | Dec 10, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905513
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.