Cleared Traditional

ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

K102425 · Zeus Scientific, Inc. · Immunology
Dec 2011
Decision
474d
Days
Class 2
Risk

About This 510(k) Submission

K102425 is an FDA 510(k) clearance for the ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 12, 2011, 474 days after receiving the submission on August 25, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K102425 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2010
Decision Date December 12, 2011
Days to Decision 474 days
Submission Type Traditional
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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