ITC-Nexus Dx

FDA Regulatory Profile

ITC-Nexus Dx appears in FDA public data with 3 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2088-2014, Class II) was initiated on June 20, 2014.

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