K-number	K981913
Device name	PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
Applicant	Chembio Diagnostic Systems, Inc.
Product code	LSR
Device class	Class II
Decision date	Feb 12, 1999
Decision	Substantially Equivalent
Regulation	866.3830

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PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY

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