Medical Device Manufacturer · CA , Toronto, Ontario

Luminex Molecular Diagnostics, Inc. - FDA 510(k) Cleared Devices

26 submissions · 22 cleared · Since 2008
26
Total
22
Cleared
2
Denied

FDA 510(k) cleared devices by Luminex Molecular Diagnostics, Inc. Microbiology

18 devices
1-12 of 18
Cleared Oct 02, 2024
NxTAG® Respiratory Pathogen Panel
K242613 · OCC
Microbiology · 29d
Cleared Mar 11, 2024
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
K231758 · QOF
Microbiology · 269d
Cleared Dec 11, 2019
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files,...
K193167 · OCC
Microbiology · 26d
Cleared Nov 12, 2019
xTAG Gastrointestinal Pathogen Panel (GPP)
K191161 · PCH
Microbiology · 195d
Cleared Nov 04, 2019
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
K191160 · PCH
Microbiology · 187d
Cleared Nov 30, 2018
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
K183023 · PCH
Microbiology · 29d
Cleared Nov 30, 2018
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS...
K183030 · PCH
Microbiology · 29d
Cleared Dec 17, 2015
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files,...
K152386 · OCC
Microbiology · 115d
Cleared Oct 24, 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR...
K140647 · PCH
Microbiology · 225d
Cleared Sep 16, 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR...
K140377 · PCH
Microbiology · 214d
Cleared Mar 21, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP...
K121894 · PCH
Microbiology · 265d
Not Cleared Jan 14, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR...
DEN130003 · PCH
Microbiology · 3d
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