Cleared Traditional

HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B

K041928 · Diagnostic Chemicals , Ltd. · Chemistry

Nov 2004

Decision

127d

Days

Class 1

Risk

About This 510(k) Submission

K041928 is an FDA 510(k) clearance for the HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on November 23, 2004, 127 days after receiving the submission on July 19, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K041928 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2004
Decision Date	November 23, 2004
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

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