510(k) Report

Devices descending from K010350

3 later devices reach Sta -Calibrator HBPM/LMWH Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111822Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWHDiagnostica Stago, Inc.201113
+1K092937Sta-Hybrid Hep CalibratorDiagnostica Stago, Inc.20100—
+2K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.20260—