510(k) K911406 ยท LBR Ldl & Vldl Precipitation, Hdl
HDL CHOLESTEROL REAGENT
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, May 22, 1991 |
| Received | Mar 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911406
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.