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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 K980351
Device Name BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
Applicant
Boston Biomedica, Inc.
375 W. St.
West Bridgewater,  MA  02379
Applicant Contact DEBRA A PETIT
Correspondent
Boston Biomedica, Inc.
375 W. St.
West Bridgewater,  MA  02379
Correspondent Contact DEBRA A PETIT
Regulation Number866.3830
Classification Product Code
LSR  
Date Received01/29/1998
Decision Date 03/05/1999
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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