Cleared Traditional

ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY

K050632 · Bayer Healthcare, LLC · Chemistry
May 2005
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K050632 is an FDA 510(k) clearance for the ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on May 26, 2005, 78 days after receiving the submission on March 9, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K050632 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2005
Decision Date May 26, 2005
Days to Decision 78 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

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