Cleared Traditional

CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT

K132711 · Carolina Liquid Chemistries Corp. · Chemistry

May 2014

Decision

252d

Days

Class 1

Risk

About This 510(k) Submission

K132711 is an FDA 510(k) clearance for the CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Carolina Liquid Chemistries Corp. (Winston-Salem, US). The FDA issued a Cleared decision on May 8, 2014, 252 days after receiving the submission on August 29, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K132711 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2013
Decision Date	May 08, 2014
Days to Decision	252 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