K-number	K010550
Device name	VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
Applicant	bioMerieux, Inc.
Product code	LTJ
Device class	Class II
Decision date	Apr 24, 2001
Decision	Substantially Equivalent
Regulation	866.6010

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VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

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