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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 K854314
Device Name FANA 60
Applicant
American Bio-Reagents, Inc.
26 N. Fourth St.
Easton,  PA  18042
Applicant Contact DAVID E KOLESAR
Correspondent
American Bio-Reagents, Inc.
26 N. Fourth St.
Easton,  PA  18042
Correspondent Contact DAVID E KOLESAR
Regulation Number866.5100
Classification Product Code
DHN  
Date Received10/28/1985
Decision Date 12/16/1985
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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