510(k) K943150 ยท MRR System, Test, Low Density, Lipoprotein
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Mar 15, 1995 |
| Received | Jun 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943150
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.