510(k) K981913

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY by Chembio Diagnostic Systems, Inc. — Product Code LSR

K981913 is an FDA 510(k) premarket notification submitted by Chembio Diagnostic Systems, Inc. for the device "PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY". The FDA issued a decision of Substantially Equivalent on February 12, 1999. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Chembio Diagnostic Systems, Inc. has at least 6 other 510(k) clearances on record.