Cleared Traditional

REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

K001398 · Corgenix, Inc. · Immunology
Mar 2001
Decision
331d
Days
Class 2
Risk

About This 510(k) Submission

K001398 is an FDA 510(k) clearance for the REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT, a System, Test, Systemic Lupus Erythematosus (Class II — Special Controls, product code DHC), submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on March 30, 2001, 331 days after receiving the submission on May 3, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5820.

Submission Details

510(k) Number K001398 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2000
Decision Date March 30, 2001
Days to Decision 331 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHC — System, Test, Systemic Lupus Erythematosus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5820

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