510(k) K014032 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Feb 8, 2002 |
| Received | Dec 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014032
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.