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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
510(k) Number K841734
Device Name TAGO FIFFU-GEN, OROSOMUCOID
Applicant
Tago, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Tago, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5420
Classification Product Code
LKL  
Date Received04/26/1984
Decision Date 06/01/1984
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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