Medical Device Manufacturer · US , Westlake , OH

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

56 submissions · 56 cleared · Since 1998

56

Total

56

Cleared

0

Denied

56 devices

51-56 of 56

Cleared Jul 24, 2000

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)

Microbiology · 66d

Cleared Jul 18, 2000

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

Microbiology · 57d

Cleared Jun 06, 2000

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)

Microbiology · 67d

Cleared May 23, 2000

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)

Microbiology · 53d

Cleared Jul 13, 1999

ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING

Microbiology · 719d

Cleared Nov 30, 1998

SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)

Microbiology · 75d