Cleared Traditional

ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM

K040111 · Zeus Scientific, Inc. · Immunology
Apr 2004
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K040111 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 5, 2004, 76 days after receiving the submission on January 20, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K040111 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2004
Decision Date April 05, 2004
Days to Decision 76 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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