Cleared Traditional

REAADS IGM ANTI-B2GP1 TEST KIT

K982433 · Corgenix, Inc. · Immunology
Dec 1998
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K982433 is an FDA 510(k) clearance for the REAADS IGM ANTI-B2GP1 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 7, 1998, 146 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 K982433 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1998
Decision Date December 07, 1998
Days to Decision 146 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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