Cleared Traditional

IGG ANTI-ATHEROX TEST KIT

K072032 · Corgenix, Inc. · Immunology
Apr 2008
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K072032 is an FDA 510(k) clearance for the IGG ANTI-ATHEROX TEST KIT, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Corgenix, Inc. (Broomfield, US). The FDA issued a Cleared decision on April 4, 2008, 255 days after receiving the submission on July 24, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K072032 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2007
Decision Date April 04, 2008
Days to Decision 255 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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