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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gastrointestinal pathogen panel multiplex nucleic acid-based assay system
510(k) Number K121894
Models I032C0316, S032-0259
Device Name XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
Original Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
suite 900
toronto,  CA m5g 1y8
Original Contact lubna syed
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Codes
JJH   NSU  
Date Received06/29/2012
Decision Date 03/21/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
statement statement
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01326013
Reviewed by Third Party No
Expedited Review No
Combination Product No
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