510(k) K971190 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Jun 16, 1997 |
| Received | Mar 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971190
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.