K-number	K050590
Device name	ENZY-WELL SYPHILIS IGG, MODEL 91106
Applicant	Diesse Diagnostica Senese S.P.A.
Product code	LIP
Device class	Class II
Decision date	Aug 10, 2006
Decision	Substantially Equivalent
Regulation	866.3830

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ENZY-WELL SYPHILIS IGG, MODEL 91106

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