Cleared Special

REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001

K034013 · Corgenix, Inc. · Immunology
Jan 2004
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K034013 is an FDA 510(k) clearance for the REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001, a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ), submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on January 8, 2004, 15 days after receiving the submission on December 24, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K034013 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2003
Decision Date January 08, 2004
Days to Decision 15 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LKJ — Antinuclear Antibody, Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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