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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, Indirect Immunofluorescent, Antigen, Control
510(k) Number K772219
Device Name FIAX TEST FOR ANTI-RUBELLA ANTIBODY
Applicant
Idt, A Division of Whittaker M.A. Bioproducts
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Idt, A Division of Whittaker M.A. Bioproducts
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5100
Classification Product Code
DHN  
Date Received12/05/1977
Decision Date 01/20/1978
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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