K-number	K050967
Device name	VARELISA RECOMBI CTD SCREEN, MODEL 13096
Applicant	Sweden Diagnostics (Germany) GmbH
Product code	LJM
Device class	Class II
Decision date	Jun 28, 2005
Decision	Substantially Equivalent
Regulation	866.5100

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VARELISA RECOMBI CTD SCREEN, MODEL 13096

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