Medical Device Manufacturer · US , Westlake , OH

Trek Diagnostic Systems, Inc.

56 submissions · 56 cleared · Since 1998
56
Total
56
Cleared
0
Denied

Trek Diagnostic Systems, Inc. — FDA 510(k) Submissions

Trek Diagnostic Systems, Inc. has submitted 56 FDA 510(k) premarket notifications since 1998, of which 56 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Manual Antimicrobial Susceptibility Test Systems, Panels, Test, Susceptibility, Antimicrobial, Susceptibility Test Plate, Antifungal, Susceptibility Test Powders, Antimycobacterial, System, Transport, Aerobic . Use the specialty filter in the sidebar to narrow results.

56 devices
1–25 of 56
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
K093865 · JWY Manual Antimicrobial... · Microbiology
Feb 2010 63d
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K090968 · NGZ Susceptibility Test... · Microbiology
Jun 2009 59d
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
K083606 · JWY Manual Antimicrobial... · Microbiology
Mar 2009 109d
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K081063 · NGZ Susceptibility Test... · Microbiology
Mar 2009 326d
SENSITITRE VIZION
K081520 · JWY Manual Antimicrobial... · Microbiology
Oct 2008 147d
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
K073653 · JWY Manual Antimicrobial... · Microbiology
Mar 2008 85d
SENSITITRE 18-24 SUSCEPTIBILITY PLATE
K073558 · JWY Manual Antimicrobial... · Microbiology
Mar 2008 85d
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K073424 · JWY Manual Antimicrobial... · Microbiology
Jan 2008 48d
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES
K062841 · JWY Manual Antimicrobial... · Microbiology
Dec 2006 89d
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062839 · JWY Manual Antimicrobial... · Microbiology
Nov 2006 49d
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062816 · JWY Manual Antimicrobial... · Microbiology
Nov 2006 42d
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062783 · JWY Manual Antimicrobial... · Microbiology
Oct 2006 38d
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062722 · JWY Manual Antimicrobial... · Microbiology
Oct 2006 38d
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062022 · JWY Manual Antimicrobial... · Microbiology
Sep 2006 56d
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K062190 · JWY Manual Antimicrobial... · Microbiology
Aug 2006 31d
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
K060783 · JWY Manual Antimicrobial... · Microbiology
May 2006 55d
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K053243 · LRG Instrument For Auto... · Microbiology
Jan 2006 60d
VERSATREK MYCO PZA KIT
K052323 · MJA Susceptibility Test... · Microbiology
Jan 2006 147d
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K052091 · JWY Manual Antimicrobial... · Microbiology
Sep 2005 50d
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040846 · JWY Manual Antimicrobial... · Microbiology
Apr 2004 25d
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040619 · JWY Manual Antimicrobial... · Microbiology
Apr 2004 29d
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K033522 · JWY Manual Antimicrobial... · Microbiology
Feb 2004 88d
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K032382 · JWY Manual Antimicrobial... · Microbiology
Aug 2003 28d
VERSATREK
K032306 · MDB System, Blood Culturing · Microbiology
Aug 2003 28d
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
K031545 · JWY Manual Antimicrobial... · Microbiology
Jul 2003 61d
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