Cleared Special

REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001

K022992 · Corgenix, Inc. · Immunology
Sep 2002
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K022992 is an FDA 510(k) clearance for the REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on September 25, 2002, 16 days after receiving the submission on September 9, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K022992 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2002
Decision Date September 25, 2002
Days to Decision 16 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MID — System, Test, Anticardiolipin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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