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FDA 510(k) Applications Submitted by LUBNA SYED
FDA 510(k) Number
Submission Date
Device Name
Applicant
DEN130003
01/11/2013
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
LUMINEX MOLECULAR DIAGNOSTICS, INC.
K130189
01/25/2013
XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
LUMINEX MOLECULAR DIAGNOSTICS, INC.
K121894
06/29/2012
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
LUMINEX MOLECULAR DIAGNOSTICS, INC.
K112199
08/01/2011
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
LUMINEX MOLECULAR DIAGNOSTICS, INC.
K112781
09/26/2011
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
LUMINEX MOLECULAR DIAGNOSTICS, INC.
K103776
12/27/2010
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
LUMINEX MOLECULAR DIAGNOSTICS, INC.
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