Name: Predicase
Price: 199 USD

K-number	DEN070004
Device name	XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065
Applicant	Cepheid
Product code	OAI
Device class	Class II
Decision date	Mar 16, 2007
Decision	Not Substantially Equivalent
Regulation	866.3225

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Source

View the full FDA submission: accessdata.fda.gov

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XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

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