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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Borrelia Serological Reagent
510(k) Number K032713
Device Name BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
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 Number866.3830
Classification Product Code
LSR  
Date Received09/02/2003
Decision Date 11/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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