Medical Device Manufacturer · US , Cleveland , OH

Trek Diagnostic Systems, Ltd. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2004

Recent clearances: SENSITITRE OPTIREAD, SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE..., SENSITITRE AIM (TM)

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Trek Diagnostic Systems, Ltd. Microbiology ✕

7 devices

1-7 of 7

Cleared Sep 22, 2011

SENSITITRE OPTIREAD

Microbiology · 205d

Cleared Aug 18, 2011

SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND...

Microbiology · 87d

Cleared Apr 27, 2011

SENSITITRE AIM (TM)

Microbiology · 83d

Cleared Feb 25, 2010

SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC...

Microbiology · 83d

Cleared Dec 16, 2009

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

Microbiology · 128d

Cleared Oct 13, 2006

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

Microbiology · 35d

Cleared Jul 27, 2004

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE...

Microbiology · 49d