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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
Device Name XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
SUITE 900
TORONTO,  CA M5G 1Y8
Applicant Contact LUBNA SYED
Correspondent
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
SUITE 900
TORONTO,  CA M5G 1Y8
Correspondent 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 (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01326013
Reviewed by Third Party No
Combination Product No
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