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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K043067
Device Name ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
Applicant
Bioarray Solutions, Ltd.
35 Technology Dr.
Suite 100
Warren,  NJ  07059
Applicant Contact KEVIN WYCKOFF
Correspondent
Bioarray Solutions, Ltd.
35 Technology Dr.
Suite 100
Warren,  NJ  07059
Correspondent Contact KEVIN WYCKOFF
Regulation Number866.5100
Classification Product Code
LLL  
Date Received11/08/2004
Decision Date 05/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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