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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transferrin, Fitc, Antigen, Antiserum, Control
510(k) Number K842071
Device Name FIAX TRANSFERRIN TEST KIT
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 Number866.5880
Classification Product Code
DDI  
Date Received05/23/1984
Decision Date 07/11/1984
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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