510(k) K021316 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Jul 25, 2002 |
| Received | Apr 25, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021316
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.