Name: Predicase
Price: 199 USD

K-number	K140377
Device name	XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)
Applicant	Luminex Molecular Diagnostics, Inc.
Product code	PCH
Device class	Class II
Decision date	Sep 16, 2014
Decision	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 GPP)

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