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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 K915272
Device Name HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
Applicant
Hemagen Diagnostics, Inc.
34 Bear Hill Rd.
Waltham,  MA  02154
Applicant Contact CHARLES A.WILLARD
Correspondent
Hemagen Diagnostics, Inc.
34 Bear Hill Rd.
Waltham,  MA  02154
Correspondent Contact CHARLES A.WILLARD
Regulation Number866.5100
Classification Product Code
LJM  
Date Received11/25/1991
Decision Date 03/17/1992
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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