Cleared Traditional

REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

K001352 · Corgenix, Inc. · Immunology
Apr 2001
Decision
346d
Days
Class 2
Risk

About This 510(k) Submission

K001352 is an FDA 510(k) clearance for the REAADS IGG 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 April 9, 2001, 346 days after receiving the submission on April 28, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5820.

Submission Details

510(k) Number K001352 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2000
Decision Date April 09, 2001
Days to Decision 346 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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