Cleared Traditional

RAICHEM LDL-CHOLESTEROL DIRECT REAGENT

K022772 · Hemagen Diagnostics, Inc. · Chemistry
Sep 2002
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K022772 is an FDA 510(k) clearance for the RAICHEM LDL-CHOLESTEROL DIRECT REAGENT, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on September 17, 2002, 27 days after receiving the submission on August 21, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K022772 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2002
Decision Date September 17, 2002
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code MRR — System, Test, Low Density, Lipoprotein
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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