Data / Medical devices / United Kingdom / Trek Diagnostic Systems, Ltd.
Trek Diagnostic Systems, Ltd.: FDA-registered device maker in East Grinstead West Sussex, United Kingdom, 81 510(k) clearances
Trek Diagnostic Systems, Ltd. is registered with the FDA (registration 8021914) in East Grinstead West Sussex, United Kingdom. It lists 11 device types. The FDA files 81 510(k) clearances under its listings, the newest dated June 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8021914
- FEI number
- 3002806332
- Address
- Units 17 - 19 Birches Industrial Estate, East Grinstead West Sussex, United Kingdom, RH19 1XZ
- Owner or operator
- Thermo Fisher Scientific (2517925)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- September 25, 1998
- Registered through
- 2026
- Brand names listed
- ARUP1MDF, CMC1AXPF, CMC1GPUF, CMC1GPVF, CMC1MDNF, CMC1OUNF, CMC1OUPF, CMC1YOGV and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 30, 2025 | K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| May 22, 2025 | K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| April 15, 2025 | K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| February 10, 2025 | K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| February 10, 2025 | K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| December 19, 2024 | K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| October 1, 2024 | K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| May 16, 2024 | K240445 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| October 31, 2023 | K232310 | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| August 31, 2023 | K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL | NGZ | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| August 25, 2023 | K231994 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| July 23, 2021 | K202612 | Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| March 12, 2020 | K193538 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| January 8, 2020 | K193024 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| November 6, 2019 | K191918 | Thermo Scientific Sensititre ARIS HiQ System | LRG | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| November 6, 2019 | K191914 | Thermo Scientific Sensititre ARIS HiQ System | LRG | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| October 16, 2019 | K192250 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| February 15, 2019 | K183324 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| January 4, 2019 | K183033 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| November 30, 2018 | K182797 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| December 1, 2017 | K173209 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| August 30, 2017 | K172274 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| December 21, 2015 | K152774 | 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 | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| August 28, 2015 | K150556 | Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| July 27, 2015 | K150236 | Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| April 1, 2015 | K143288 | Sensititre Susceptibility plates | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| March 5, 2015 | K143526 | The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| March 2, 2015 | K142338 | Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| February 19, 2015 | K143381 | Sensititre Susceptibility Plates | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| December 23, 2014 | K142151 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| October 21, 2014 | K141651 | SENSITITRE SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| June 10, 2014 | K140985 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| January 31, 2014 | K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | NGZ | Substantially Equivalent | Trek Diagnostic Systems | accessdata.fda.gov |
| November 16, 2011 | K112276 | VIZION | JWY | Substantially Equivalent | Trek Diagnostic Systems | accessdata.fda.gov |
| September 22, 2011 | K110583 | SENSITITRE OPTIREAD | LRG | Substantially Equivalent | Trek Diagnostic Systems, Ltd. | accessdata.fda.gov |
| August 18, 2011 | K111429 | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... | JWY | Substantially Equivalent | Trek Diagnostic Systems, Ltd. | accessdata.fda.gov |
| June 22, 2011 | K103456 | THE SENSITITRE AIM | LIE | Substantially Equivalent | Trek Diagnostic Systems | accessdata.fda.gov |
| April 27, 2011 | K110331 | SENSITITRE AIM (TM) | LIE | Substantially Equivalent | Trek Diagnostic Systems, Ltd. | accessdata.fda.gov |
| February 17, 2010 | K093865 | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| December 16, 2009 | K092445 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Trek Diagnostic Systems, Ltd. | accessdata.fda.gov |
| June 4, 2009 | K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | NGZ | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| March 24, 2009 | K083606 | SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| March 6, 2009 | K081063 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | NGZ | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| October 24, 2008 | K081520 | SENSITITRE VIZION | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| March 20, 2008 | K073653 | SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| March 13, 2008 | K073558 | SENSITITRE 18-24 SUSCEPTIBILITY PLATE | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| January 22, 2008 | K073424 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| May 16, 2006 | K060783 | SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| April 21, 2006 | K060621 | SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- | JWY | Substantially Equivalent | Tds Holdings, Inc. | accessdata.fda.gov |
| September 21, 2005 | K052091 | SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| April 26, 2004 | K040846 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| April 7, 2004 | K040619 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| February 3, 2004 | K033522 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| July 16, 2003 | K031545 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| March 6, 2003 | K024353 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | LTT | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| May 15, 2002 | K020859 | CEFOTAXIME | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| November 20, 2001 | K013368 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | LTT | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| November 2, 2001 | K012921 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| October 30, 2001 | K012895 | HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| October 9, 2001 | K991810 | MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST | NGZ | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| August 29, 2001 | K012151 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| August 15, 2001 | K011803 | SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| February 27, 2001 | K003868 | SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| July 24, 2000 | K001558 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| June 6, 2000 | K001036 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| May 23, 2000 | K001035 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) | JWY | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| November 30, 1998 | K983244 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) | JTW | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| January 22, 1998 | K972576 | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 | LQL | Substantially Equivalent | Accumed Intl., Inc. | accessdata.fda.gov |
| March 19, 1997 | K965190 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE | JWY | Substantially Equivalent | Accumed Intl., Inc. | accessdata.fda.gov |
| September 30, 1996 | K962867 | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Sensititre Alamar | accessdata.fda.gov |
| April 9, 1996 | K960366 | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | LTT | Substantially Equivalent | Accumed Intl., Inc. | accessdata.fda.gov |
| March 27, 1996 | K960235 | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Accumed Intl., Inc. | accessdata.fda.gov |
| March 11, 1996 | K960220 | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Sensititre , Ltd. | accessdata.fda.gov |
| October 7, 1995 | K951241 | HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE | JWY | Substantially Equivalent | Radiometer America, Inc. | accessdata.fda.gov |
| July 13, 1995 | K936305 | SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Radiometer America, Inc. | accessdata.fda.gov |
| March 9, 1993 | K923045 | SENSITITRE SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Radiometer America, Inc. | accessdata.fda.gov |
| February 18, 1992 | K912778 | HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE | JWY | Substantially Equivalent | Sensititre Microbiology A Div. of Radiometer | accessdata.fda.gov |
| June 9, 1989 | K890057 | SENSITITRE AUTO ID PLATE AP80 | LQM | Substantially Equivalent | Radiometer America, Inc. | accessdata.fda.gov |
| May 13, 1988 | K880641 | SENSITITRE STABILITY PLATES | JWY | Substantially Equivalent | Sensititre , Ltd. | accessdata.fda.gov |
| May 6, 1986 | K860753 | SENSITITRE SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | Gibco Laboratories Life Technologies, Inc. | accessdata.fda.gov |
| December 22, 1980 | K802957 | MUELLER HINTON BROTH | JTZ | Substantially Equivalent | Gibco Laboratories Life Technologies, Inc. | accessdata.fda.gov |
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Updated June 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.