510(k) K983726 ยท LCP Assay, Glycosylated Hemoglobin
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Nov 25, 1998 |
| Received | Oct 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983726
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.