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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 K983423
Device Name THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 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
LLL  
Date Received09/29/1998
Decision Date 11/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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