Cleared Traditional

REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT

K000920 · Corgenix, Inc. · Immunology
Apr 2000
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K000920 is an FDA 510(k) clearance for the REAADS IGA ANTI-PHOSPHATIDYLSERINE 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 April 26, 2000, 35 days after receiving the submission on March 22, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K000920 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2000
Decision Date April 26, 2000
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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