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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 K862087
Device Name SANTEST 1AP
Applicant
Scientific Sales Intl., Inc.
P.O. Box 1538
Kalamazoo,  MI  49005
Applicant Contact NICOLAS SCHMELZER
Correspondent
Scientific Sales Intl., Inc.
P.O. Box 1538
Kalamazoo,  MI  49005
Correspondent Contact NICOLAS SCHMELZER
Regulation Number866.5420
Classification Product Code
LKL  
Date Received06/02/1986
Decision Date 12/03/1986
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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