Medical Device Manufacturer · US , Cleveland , OH

Trek Diagnostic Systems, Ltd.

7 submissions · 7 cleared · Since 2004
7
Total
7
Cleared
0
Denied

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

Trek Diagnostic Systems, Ltd. has submitted 7 FDA 510(k) premarket notifications since 2004, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Manual Antimicrobial Susceptibility Test Systems, Reagent/device, Inoculum Calibration, Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
SENSITITRE OPTIREAD
K110583 · LRG Instrument For Auto... · Microbiology
Sep 2011 205d
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
K111429 · JWY Manual Antimicrobial... · Microbiology
Aug 2011 87d
SENSITITRE AIM (TM)
K110331 · LIE Reagent/device, Inoculum... · Microbiology
Apr 2011 83d
SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES
K093741 · JWY Manual Antimicrobial... · Microbiology
Feb 2010 83d
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K092445 · JWY Manual Antimicrobial... · Microbiology
Dec 2009 128d
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062681 · JWY Manual Antimicrobial... · Microbiology
Oct 2006 35d
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL
K041534 · JWY Manual Antimicrobial... · Microbiology
Jul 2004 49d
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