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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K973822
Device Name VIRGO ANCA SCREEN KIT
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 Number866.5660
Classification Product Code
MOB  
Date Received10/07/1997
Decision Date 11/13/1997
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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