510(k) K000239 ยท LCP Assay, Glycosylated Hemoglobin
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Mar 21, 2000 |
| Received | Jan 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000239
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.