Cleared Special

RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER

K023784 · Hemagen Diagnostics, Inc. · Chemistry
Dec 2002
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K023784 is an FDA 510(k) clearance for the RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on December 24, 2002, 42 days after receiving the submission on November 12, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K023784 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2002
Decision Date December 24, 2002
Days to Decision 42 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LBR — Ldl & Vldl Precipitation, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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