Cleared Traditional

HDL CHOLESTEROL REAGENT, MODEL 10211

K073497 · Medica Corp. · Chemistry

Apr 2008

Decision

123d

Days

Class 1

Risk

About This 510(k) Submission

K073497 is an FDA 510(k) clearance for the HDL CHOLESTEROL REAGENT, MODEL 10211, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on April 14, 2008, 123 days after receiving the submission on December 13, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K073497 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2007
Decision Date	April 14, 2008
Days to Decision	123 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