Cleared Special

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT

K013080 · Corgenix, Inc. · Immunology
Sep 2001
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K013080 is an FDA 510(k) clearance for the REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on September 28, 2001, 14 days after receiving the submission on September 14, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K013080 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2001
Decision Date September 28, 2001
Days to Decision 14 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement

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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