Name: Predicase
Price: 199 USD

K-number	K191160
Device name	xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Applicant	Luminex Molecular Diagnostics, Inc.
Product code	PCH
Device class	Class II
Decision date	Nov 4, 2019
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 (TDAS GPP)

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