510(k) K992766 ยท MRR System, Test, Low Density, Lipoprotein
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Oct 18, 1999 |
| Received | Aug 17, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992766
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.