FDA 510(k) Applications Submitted by TINA IP
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140377 |
02/14/2014 |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K140647 |
03/13/2014 |
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K191160 |
05/01/2019 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
| K191161 |
05/01/2019 |
xTAG Gastrointestinal Pathogen Panel (GPP) |
Luminex Molecular Diagnostics, Inc. |
| K152386 |
08/24/2015 |
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K183023 |
11/01/2018 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
| K183030 |
11/01/2018 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
| K163347 |
11/28/2016 |
xTAG Cystic Fibrosis 39 Kit v2 |
Luminex Molecular Diagnostics, Inc. |
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