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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 K902139
Device Name HEMAGEN ENA [JO-I] KIT
Applicant
Hemagen Diagnostics, Inc.
34 Bear Hill Rd.
Waltham,  MA  02154
Applicant Contact CHARLES A WILLAND
Correspondent
Hemagen Diagnostics, Inc.
34 Bear Hill Rd.
Waltham,  MA  02154
Correspondent Contact CHARLES A WILLAND
Regulation Number866.5100
Classification Product Code
DHN  
Date Received05/09/1990
Decision Date 05/18/1990
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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