Cleared Special

REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT

K013018 · Corgenix, Inc. · Immunology
Sep 2001
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K013018 is an FDA 510(k) clearance for the REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE 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 September 20, 2001, 13 days after receiving the submission on September 7, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K013018 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2001
Decision Date September 20, 2001
Days to Decision 13 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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