Cleared Special

REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139

K032868 · Corgenix, Inc. · Immunology
Oct 2003
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K032868 is an FDA 510(k) clearance for the REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139, 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 October 14, 2003, 29 days after receiving the submission on September 15, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K032868 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2003
Decision Date October 14, 2003
Days to Decision 29 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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