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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igg, Antigen, Antiserum, Control
510(k) Number K924197
Device Name ZORBA(TM) IGG REMOVAL REAGENT
Applicant
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN,  NJ  08869
Applicant Contact JOSEPH A ROSEBROCK
Correspondent
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN,  NJ  08869
Correspondent Contact JOSEPH A ROSEBROCK
Regulation Number866.5510
Classification Product Code
DEW  
Date Received08/20/1992
Decision Date 12/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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