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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 K882369
Device Name ACCRAASSAY RID KITS
Applicant
Icn Immunobiologicals
P.O. Box 1200
Lisle,  IL  60532
Applicant Contact L. G SUDBURY
Correspondent
Icn Immunobiologicals
P.O. Box 1200
Lisle,  IL  60532
Correspondent Contact L. G SUDBURY
Regulation Number866.5510
Classification Product Code
DEW  
Date Received06/08/1988
Decision Date 07/12/1988
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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