ITC-Nexus Dx

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2088-2014Class IIHemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation June 20, 2014
Z-0937-2014Class IIHemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be December 19, 2013
Z-0137-2014Class IISurgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen AvenuAugust 22, 2013