Cleared Traditional

ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)

K071706 · Clinical Data, Inc. · Chemistry

Dec 2007

Decision

182d

Days

Class 1

Risk

About This 510(k) Submission

K071706 is an FDA 510(k) clearance for the ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118), a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on December 20, 2007, 182 days after receiving the submission on June 21, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K071706 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2007
Decision Date	December 20, 2007
Days to Decision	182 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