Cleared Traditional

Direct HDL Cholesterol (HDL)

K153435 · Randox Laboratories, Ltd. · Chemistry

Jan 2016

Decision

42d

Days

Class 1

Risk

About This 510(k) Submission

K153435 is an FDA 510(k) clearance for the Direct HDL Cholesterol (HDL), a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 8, 2016, 42 days after receiving the submission on November 27, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K153435 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 2015
Decision Date	January 08, 2016
Days to Decision	42 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