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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 K140647
Device Name XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
TORONTO, ONTARIO,  CA M5G 1Y8
Applicant Contact Tina Ip
Correspondent
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
TORONTO, ONTARIO,  CA M5G 1Y8
Correspondent Contact Tina Ip
Regulation Number866.3990
Classification Product Code
PCH  
Date Received03/13/2014
Decision Date 10/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01326013
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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