510(k) Report

Devices descending from K943520

3 later devices reach Heparin Control 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
+1K051472Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh CalibratorHyphen Biomed200504
+2K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.20260—