Cleared Traditional

ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM

K042092 · Zeus Scientific, Inc. · Microbiology
Apr 2005
Decision
252d
Days
Class 1
Risk

About This 510(k) Submission

K042092 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM, a Antibody Igm, If, Epstein-barr Virus (Class I — General Controls, product code LJN), submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on April 12, 2005, 252 days after receiving the submission on August 3, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K042092 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2004
Decision Date April 12, 2005
Days to Decision 252 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LJN — Antibody Igm, If, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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