Cleared Traditional

REAADS IGA ANTI-B2GP 1 TEST KIT

K982434 · Corgenix, Inc. · Immunology
Dec 1998
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K982434 is an FDA 510(k) clearance for the REAADS IGA ANTI-B2GP 1 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 December 22, 1998, 161 days after receiving the submission on July 14, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K982434 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1998
Decision Date December 22, 1998
Days to Decision 161 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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