510(k) K980351

BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT by Boston Biomedica, Inc. — Product Code LSR

K980351 is an FDA 510(k) premarket notification submitted by Boston Biomedica, Inc. for the device "BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT". The FDA issued a decision of Substantially Equivalent on March 5, 1999. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Boston Biomedica, Inc. has at least 10 other 510(k) clearances on record.