FDA 510(k) Applications Submitted by TREK DIAGNOSTIC SYSTEMS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K033522 11/07/2003 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K093865 12/16/2009 SENSITITRE 18-24HR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K021339 03/07/2002 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE TREK DIAGNOSTIC SYSTEMS, INC.
K090968 04/06/2009 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K062816 09/20/2006 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K012895 08/28/2001 HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE TREK DIAGNOSTIC SYSTEMS, INC.
K020762 03/07/2002 GATIFLOXIN TREK DIAGNOSTIC SYSTEMS, INC.
K040619 03/09/2004 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K020859 03/18/2002 CEFOTAXIME TREK DIAGNOSTIC SYSTEMS, INC.
K060783 03/22/2006 SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL TREK DIAGNOSTIC SYSTEMS, INC.
K001035 03/31/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) TREK DIAGNOSTIC SYSTEMS, INC.
K001036 03/31/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) TREK DIAGNOSTIC SYSTEMS, INC.
K040846 04/01/2004 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K081063 04/14/2008 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC.
K031545 05/16/2003 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K021627 05/17/2002 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K001558 05/19/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) TREK DIAGNOSTIC SYSTEMS, INC.
K001573 05/22/2000 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K991810 05/27/1999 MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST TREK DIAGNOSTIC SYSTEMS, INC.
K081520 05/30/2008 SENSITITRE VIZION TREK DIAGNOSTIC SYSTEMS, INC.
K011803 06/11/2001 SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K021997 06/19/2002 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K012151 07/10/2001 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K062022 07/17/2006 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K062190 07/31/2006 SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K032382 08/01/2003 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K052091 08/02/2005 SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC.
K012565 08/09/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K022656 08/09/2002 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K022775 08/09/2002 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K012921 08/31/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K062722 09/12/2006 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K013075 09/14/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K983244 09/16/1998 SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) TREK DIAGNOSTIC SYSTEMS, INC.
K062783 09/18/2006 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K062839 09/21/2006 MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K062841 09/22/2006 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K013195 09/25/2001 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K013368 10/11/2001 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K013580 10/29/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K013925 11/14/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K053243 11/21/2005 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K073424 12/05/2007 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K083606 12/05/2008 SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K003834 12/12/2000 SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC.
K003868 12/14/2000 SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC.
K073558 12/19/2007 SENSITITRE 18-24 SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K014259 12/26/2001 SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K014258 12/26/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K073653 12/26/2007 SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K004045 12/29/2000 SUSCEPTIBILITY TEST PANEL TREK DIAGNOSTIC SYSTEMS, INC.
K024353 12/30/2002 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K024357 12/30/2002 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K972772 07/24/1997 ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING TREK DIAGNOSTIC SYSTEMS, INC.
K032306 07/25/2003 VERSATREK TREK DIAGNOSTIC SYSTEMS, INC.
K052323 08/25/2005 VERSATREK MYCO PZA KIT TREK DIAGNOSTIC SYSTEMS, INC.


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