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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 (Enzyme-Labeled), Antigen, Controls
510(k) Number K862969
Device Name ANA-ENZYME IMMUNOASSAY (ANA-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
LJM  
Date Received08/06/1986
Decision Date 10/24/1986
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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