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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
510(k) Number K924186
Device Name LPIA-FERRITIN ASSAY
Applicant
SERADYN, INC.
P.O. BOX 1210
INDIANAPOLIS,  IN  46206
Applicant Contact ANDRIS INDRIKSONS
Correspondent
SERADYN, INC.
P.O. BOX 1210
INDIANAPOLIS,  IN  46206
Correspondent Contact ANDRIS INDRIKSONS
Regulation Number866.5425
Classification Product Code
DEF  
Date Received08/20/1992
Decision Date 12/23/1992
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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