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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 K790464
Device Name FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO
Applicant
Intl. Diagnostic Technology
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Intl. Diagnostic Technology
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3780
Classification Product Code
GLZ  
Date Received03/05/1979
Decision Date 06/13/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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