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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
510(k) Number K992224
Device Name VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
Applicant
Hemagen Diagnostics, Inc.
40 Bear Hill Rd.
Waltham,  MA  02451
Applicant Contact JOSEPH M CALIFANO
Correspondent
Hemagen Diagnostics, Inc.
40 Bear Hill Rd.
Waltham,  MA  02451
Correspondent Contact JOSEPH M CALIFANO
Regulation Number866.5660
Classification Product Code
MSV  
Date Received07/01/1999
Decision Date 08/30/1999
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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