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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K842533
Device Name AMIZYME-ANDNA TEST KIT
Applicant
Amico Lab, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Amico Lab, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5100
Classification Product Code
LJM  
Date Received06/28/1984
Decision Date 09/20/1984
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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