Cleared Traditional

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

K103747 · Elitechgroup Seppim S.A.S. · Chemistry

Aug 2011

Decision

251d

Days

Class 1

Risk

About This 510(k) Submission

K103747 is an FDA 510(k) clearance for the ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Elitechgroup Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on August 31, 2011, 251 days after receiving the submission on December 23, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K103747 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2010
Decision Date	August 31, 2011
Days to Decision	251 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1475