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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, antigen, control
510(k) Number K042416
Device Name ATHENA MULTI-LYTE ANA-II TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN,  NJ  08869
Applicant Contact MARK J KOPNITSKY
Correspondent
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN,  NJ  08869
Correspondent Contact MARK J KOPNITSKY
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received09/07/2004
Decision Date 10/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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