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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, anticardiolipin immunological
510(k) Number K102425
Device Name ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG,  NJ  08876
Applicant Contact EWA NADOLCZAK
Correspondent
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG,  NJ  08876
Correspondent Contact EWA NADOLCZAK
Regulation Number866.5660
Classification Product Code
MID  
Date Received08/25/2010
Decision Date 12/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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