Company ยท US
Trek Diagnostic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2014. Name variants (Inc, Corp, punctuation) are merged.
68510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 51 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 4 |
| MDB | System, Blood Culturing | 4 |
| NGZ | Susceptibility Test Plate, Antifungal | 4 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 3 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 |
| LIE | Reagent/Device, Inoculum Calibration | 2 |
| MJA | Susceptibility Test Powders, Antimycobacterial | 2 |
| JTW | System, Transport, Aerobic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2014 | K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES Trek Diagnostic Systems | NGZ |
| Nov 16, 2011 | K112276 | VIZION Trek Diagnostic Systems | JWY |
| Nov 8, 2011 | K111615 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES Trek Diagnostic Systems | JWY |
| Sep 22, 2011 | K110583 | SENSITITRE OPTIREAD Trek Diagnostic Systems, Ltd. | LRG |
| Aug 26, 2011 | K103532 | AUTOREADER 2 Trek Diagnostic Systems | LRG |
| Aug 18, 2011 | K111429 | 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. | JWY |
| Jun 22, 2011 | K103456 | THE SENSITITRE AIM Trek Diagnostic Systems | LIE |
| Apr 27, 2011 | K110331 | SENSITITRE AIM (TM) Trek Diagnostic Systems, Ltd. | LIE |
| Feb 25, 2010 | K093741 | SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Ltd. | JWY |
| Feb 17, 2010 | K093865 | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Dec 16, 2009 | K092445 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Ltd. | JWY |
| Jun 4, 2009 | K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | NGZ |
| Mar 24, 2009 | K083606 | SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Mar 6, 2009 | K081063 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS Trek Diagnostic Systems, Inc. | NGZ |
| Oct 24, 2008 | K081520 | SENSITITRE VIZION Trek Diagnostic Systems, Inc. | JWY |
| Mar 20, 2008 | K073653 | SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE Trek Diagnostic Systems, Inc. | JWY |
| Mar 13, 2008 | K073558 | SENSITITRE 18-24 SUSCEPTIBILITY PLATE Trek Diagnostic Systems, Inc. | JWY |
| Jan 22, 2008 | K073424 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Dec 20, 2006 | K062841 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Nov 9, 2006 | K062839 | MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Nov 1, 2006 | K062816 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Oct 26, 2006 | K062783 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Oct 20, 2006 | K062722 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Oct 13, 2006 | K062681 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Ltd. | JWY |
| Sep 11, 2006 | K062022 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Aug 31, 2006 | K062190 | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES Trek Diagnostic Systems, Inc. | JWY |
| May 16, 2006 | K060783 | SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL Trek Diagnostic Systems, Inc. | JWY |
| Jan 20, 2006 | K053243 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | LRG |
| Jan 19, 2006 | K052323 | VERSATREK MYCO PZA KIT Trek Diagnostic Systems, Inc. | MJA |
| Sep 21, 2005 | K052091 | SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS Trek Diagnostic Systems, Inc. | JWY |
| Jul 27, 2004 | K041534 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL Trek Diagnostic Systems, Ltd. | JWY |
| Apr 26, 2004 | K040846 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES Trek Diagnostic Systems, Inc. | JWY |
| Apr 7, 2004 | K040619 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES Trek Diagnostic Systems, Inc. | JWY |
| Feb 3, 2004 | K033522 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Aug 29, 2003 | K032382 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES Trek Diagnostic Systems, Inc. | JWY |
| Aug 22, 2003 | K032306 | VERSATREK Trek Diagnostic Systems, Inc. | MDB |
| Jul 16, 2003 | K031545 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE Trek Diagnostic Systems, Inc. | JWY |
| Mar 17, 2003 | K024357 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | LTT |
| Mar 6, 2003 | K024353 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | LTT |
| Oct 8, 2002 | K022656 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Sep 25, 2002 | K022775 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Sep 25, 2002 | K021997 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Jun 20, 2002 | K021627 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| May 15, 2002 | K020859 | CEFOTAXIME Trek Diagnostic Systems, Inc. | JWY |
| May 9, 2002 | K021339 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE Trek Diagnostic Systems, Inc. | JWY |
| May 9, 2002 | K020762 | GATIFLOXIN Trek Diagnostic Systems, Inc. | JWY |
| Mar 26, 2002 | K014259 | SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Feb 19, 2002 | K014258 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | JWY |
| Dec 21, 2001 | K013925 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | JWY |
| Dec 12, 2001 | K013580 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE Trek Diagnostic Systems, Inc. | JWY |
Newest 50 of 68.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2012 | Trek Diagnostic Systems VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer
T Terminated |
MDB | K032306 |
| Sep 30, 2009 | Trek Diagnostic Systems Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA.
In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Str Terminated |
JTZ | K860753 |
| Jan 28, 2009 | Trek Diagnostic Systems HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box Terminated |
JTZ | None listed |
| Sep 14, 2005 | Trek Diagnostic Systems VersaTREK Myco AS. Terminated |
MDB | None listed |
| Apr 13, 2005 | Trek Diagnostic Systems Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case. Terminated |
MDB | None listed |