510(k) K971573 ยท LBR Ldl & Vldl Precipitation, Hdl
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Jun 18, 1997 |
| Received | Apr 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971573
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.