Cleared Traditional

POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC

K100550 · Polymedco, Inc. · Chemistry

Sep 2010

Decision

214d

Days

Class 1

Risk

About This 510(k) Submission

K100550 is an FDA 510(k) clearance for the POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on September 28, 2010, 214 days after receiving the submission on February 26, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K100550 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2010
Decision Date	September 28, 2010
Days to Decision	214 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