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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 K870458
Device Name HISTONES EIA DIAGNOSTIC KIT
Applicant
Biohytech International, Inc.
10 W. 35th St.
Chicago,  IL  60616
Applicant Contact HIRSCH, PHD
Correspondent
Biohytech International, Inc.
10 W. 35th St.
Chicago,  IL  60616
Correspondent Contact HIRSCH, PHD
Regulation Number866.5100
Classification Product Code
DHN  
Date Received01/21/1987
Decision Date 03/17/1987
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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