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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 K962276
Device Name HEMAGEN ENA DSDNA KIT (EIA METHOD)
Applicant
Hemagen Diagnostics, Inc.
34-40 Bear Hill Rd.
Waltham,  MA  02154
Applicant Contact JOSEPH M CALIFANO
Correspondent
Hemagen Diagnostics, Inc.
34-40 Bear Hill Rd.
Waltham,  MA  02154
Correspondent Contact JOSEPH M CALIFANO
Regulation Number866.5100
Classification Product Code
DHN  
Date Received06/13/1996
Decision Date 12/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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