Cleared Special

MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT

K012567 · Corgenix, Inc. · Immunology
Aug 2001
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K012567 is an FDA 510(k) clearance for the MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM 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 August 23, 2001, 14 days after receiving the submission on August 9, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K012567 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2001
Decision Date August 23, 2001
Days to Decision 14 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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