Name: Predicase
Price: 199 USD

K-number	DEN130003
Device name	XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
Applicant	Luminex Molecular Diagnostics, Inc.
Product code	PCH
Device class	Class II
Decision date	Jan 14, 2013
Decision	Not Substantially Equivalent
Regulation	866.3990

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Source

View the full FDA submission: accessdata.fda.gov

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XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)

Everything you need for a 510(k) submission. Nothing you don't.