FDA 510(k) Applications Submitted by CYNTHIA C KNAPP

FDA 510(k) Number Submission Date Device Name Applicant
K150236 02/02/2015 Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) THERMO FISHER SCIENTIFIC
K150556 03/04/2015 Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) THERMO FISHER SCIENTIFIC
K090968 04/06/2009 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC.
K140985 04/16/2014 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES Thermo Fisher Scientific
K141000 04/18/2014 SENSITITRE SUSCEPTIBILITY PLATES Thermo Fisher Scientific
K141651 06/20/2014 SENSITITRE SUSCEPTIBILITY PLATES Thermo Fisher Scientific
K171870 06/22/2017 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 û 8 ug/mL Thermo Fisher Scientific
K181946 07/20/2018 Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL Thermo Fisher Scientific
K172274 07/28/2017 The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8?g/mL Thermo Fisher Scientific
K142151 08/06/2014 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Thermo Fisher Scientific
K172454 08/14/2017 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL Thermo Fisher Scientific
K142338 08/21/2014 Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) THERMO FISHER SCIENTIFIC
K062816 09/20/2006 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K162620 09/20/2016 Remel Spectra ESBL REMEL, INC.
K152774 09/25/2015 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL THERMO FISHER SCIENTIFIC
K173209 10/02/2017 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL Thermo Fisher Scientific
K143288 11/17/2014 Sensititre Susceptibility plates THERMO FISHER SCIENTIFIC
K143381 11/25/2014 Sensititre Susceptibility Plates Thermo Fisher Scientific
K103532 12/01/2010 AUTOREADER 2 TREK DIAGNOSTIC SYSTEMS
K093741 12/04/2009 SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, LTD.
K133773 12/12/2013 SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM Thermo Fisher Scientific
K143526 12/12/2014 The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) Thermo Fisher Scientfic
K133847 12/18/2013 SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES Thermo Fisher Scientific
K110331 02/03/2011 SENSITITRE AIM (TM) TREK DIAGNOSTIC SYSTEMS, LTD.
K110583 03/01/2011 SENSITITRE OPTIREAD TREK DIAGNOSTIC SYSTEMS, LTD.
K020762 03/07/2002 GATIFLOXIN TREK DIAGNOSTIC SYSTEMS, INC.
K060621 03/08/2006 SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- TDS HOLDINGS 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.
K111429 05/23/2011 SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... TREK DIAGNOSTIC SYSTEMS, LTD.
K991810 05/27/1999 MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST TREK DIAGNOSTIC SYSTEMS, INC.
K972756 05/30/1997 MODIFICATION OF EST CULTURE SYSTEM II - MYCO ACCUMED INTL., INC.
K081520 05/30/2008 SENSITITRE VIZION TREK DIAGNOSTIC SYSTEMS, INC.
K041534 06/08/2004 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL TREK DIAGNOSTIC SYSTEMS, LTD.
K111615 06/10/2011 SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS
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.
K112276 08/09/2011 VIZION TREK DIAGNOSTIC SYSTEMS
K092445 08/10/2009 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, LTD.
K012921 08/31/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K062681 09/08/2006 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, LTD.
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.
K983301 09/21/1998 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN ACCUMED INTL., INC.
K983306 09/21/1998 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN ACCUMED INTL., INC.
K983309 09/21/1998 SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN ACCUMED INTL., INC.
K983310 09/21/1998 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN ACCUMED INTL., 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.
K103456 11/24/2010 THE SENSITITRE AIM TREK DIAGNOSTIC SYSTEMS
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.
K984489 12/17/1998 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES ACCUMED INTL., INC.
K073558 12/19/2007 SENSITITRE 18-24 SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K965190 12/24/1996 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE ACCUMED INTL., INC.
K014258 12/26/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC.
K014259 12/26/2001 SENSITITRE HEAMOPHILUS/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.


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