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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 K873868
Device Name ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
Applicant
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Applicant Contact GEORGE ZAJICEK
Correspondent
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Correspondent Contact GEORGE ZAJICEK
Regulation Number866.5420
Classification Product Code
LKL  
Date Received08/24/1987
Decision Date 10/20/1987
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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