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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibody Igm,If, Cytomegalovirus Virus
510(k) Number K972884
Device Name ACCURUN 146 CMV IGM POSITIVE CONTROL
Applicant
Boston Biomedica, Inc.
375 W. St.
West Bridgewater,  MA  02379
Applicant Contact PATRICIA E GARRETT
Correspondent
Boston Biomedica, Inc.
375 W. St.
West Bridgewater,  MA  02379
Correspondent Contact PATRICIA E GARRETT
Regulation Number866.3175
Classification Product Code
LKQ  
Date Received08/05/1997
Decision Date 08/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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