Cleared Traditional

REAADS IGG ANTI-B2GPI TEST KIT

K982391 · Corgenix, Inc. · Immunology
Dec 1998
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K982391 is an FDA 510(k) clearance for the REAADS IGG ANTI-B2GPI 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, 151 days after receiving the submission on July 9, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K982391 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1998
Decision Date December 07, 1998
Days to Decision 151 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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