Cleared Special

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

K031208 · Corgenix, Inc. · Immunology
Jul 2003
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K031208 is an FDA 510(k) clearance for the REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001, 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 July 7, 2003, 81 days after receiving the submission on April 17, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K031208 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2003
Decision Date July 07, 2003
Days to Decision 81 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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