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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K946123
Device Name HEMAGEN ENA SM 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
LLL  
Date Received12/15/1994
Decision Date 02/22/1995
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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