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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, If, Toxoplasma Gondii
510(k) Number K842664
Device Name ANTI-TOXOPLASMA GONDII 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 Number866.3780
Classification Product Code
GLZ  
Date Received07/10/1984
Decision Date 08/28/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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