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FDA 510(k) Application Details - K140377
Device Classification Name
More FDA Info for this Device
510(K) Number
K140377
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 M5G 1Y8 CA
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Tina Ip
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Regulation Number
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Classification Product Code
PCH
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Date Received
02/14/2014
Decision Date
09/16/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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