Cleared Special

REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT

K024196 · Corgenix, Inc. · Immunology
Jan 2003
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K024196 is an FDA 510(k) clearance for the REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT, 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 January 3, 2003, 14 days after receiving the submission on December 20, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K024196 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2002
Decision Date January 03, 2003
Days to Decision 14 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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