510(k) K962186 ยท LBR Ldl & Vldl Precipitation, Hdl
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Aug 19, 1996 |
| Received | Jun 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962186
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.