510(k) K103747 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
| Applicant | Elitechgroup Seppim S.A.S., Bothell WA, US |
| Decision | Substantially Equivalent, Aug 31, 2011 |
| Received | Dec 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103747
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.