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Trek Diagnostic Systems

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
68
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2323-2012Class IIIVersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD wiJuly 23, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K133038SENSITITRE YEASTONE SUSCEPTIBILITY PLATESJanuary 31, 2014
K112276VIZIONNovember 16, 2011
K111615SENSITITRE 18-24 HR SUSCEPTIBILITY PLATESNovember 8, 2011
K110583SENSITITRE OPTIREADSeptember 22, 2011
K103532AUTOREADER 2August 26, 2011
K111429SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-August 18, 2011
K103456THE SENSITITRE AIMJune 22, 2011
K110331SENSITITRE AIM (TM)April 27, 2011
K093741SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATESFebruary 25, 2010
K093865SENSITITRE 18-24HR SUSCEPTIBILITY PLATESFebruary 17, 2010
K092445SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESDecember 16, 2009
K090968SENSITITRE YEASTONE SUSCEPTIBILITY PLATESJune 4, 2009
K083606SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATESMarch 24, 2009
K081063SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICSMarch 6, 2009
K081520SENSITITRE VIZIONOctober 24, 2008
K073653SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATEMarch 20, 2008
K073558SENSITITRE 18-24 SUSCEPTIBILITY PLATEMarch 13, 2008
K073424SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESJanuary 22, 2008
K062841SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATESDecember 20, 2006
K062839MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATENovember 9, 2006