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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K000879
Device Name THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
Applicant
Zeus Scientific, Inc.
200 Evans Way
Branchburg,  NJ  08876
Applicant Contact MARK J KOPNITSKY
Correspondent
Zeus Scientific, Inc.
200 Evans Way
Branchburg,  NJ  08876
Correspondent Contact MARK J KOPNITSKY
Regulation Number866.5100
Classification Product Code
LJM  
Date Received03/20/2000
Decision Date 05/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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