510(k) K895139 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
CLINISTAT HDL CHOLESTEROL REAGENT TEST
| Applicant | Heraeus Kulzer, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Dec 27, 1989 |
| Received | Aug 16, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895139
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.