ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS

Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

ELITECHGROUP SEPPIM S.A.S.

The following data is part of a premarket notification filed by Elitechgroup Seppim S.a.s. with the FDA for Elitech Clincal Systems Cholesterol Hdl Sl 2g, Hdl 2g Calibrator, Ldl Sl 2g, Ldl 2g Calibrator, Elitrol Ii & Elitech Sys.

Pre-market Notification Details

Device IDK103747
510k NumberK103747
Device Name:ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
ClassificationLdl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Applicant ELITECHGROUP SEPPIM S.A.S. 21720 23RD DR SE, SUITE 150 Bothell,  WA  98021
ContactDebra K Hutson
CorrespondentDebra K Hutson
ELITECHGROUP SEPPIM S.A.S. 21720 23RD DR SE, SUITE 150 Bothell,  WA  98021
Product CodeLBS  
Subsequent Product CodeJIT
Subsequent Product CodeJJY
Subsequent Product CodeMRR
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-23
Decision Date2011-08-31
Summary:summary

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