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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 K872845
Device Name BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
Applicant
Bion Ent., Ltd.
674 Busse Hwy.
Park Ridge,  IL  60068
Applicant Contact EDWARD NOWAKOWSKI
Correspondent
Bion Ent., Ltd.
674 Busse Hwy.
Park Ridge,  IL  60068
Correspondent Contact EDWARD NOWAKOWSKI
Regulation Number866.5100
Classification Product Code
DHN  
Date Received07/20/1987
Decision Date 08/17/1987
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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