510(k) Report

Devices descending from K812424

3 later devices reach CI-Trol Heparin Controls, Low/High through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042941Dade Behring Heparin Calibrator and ControlsDade Behring, Inc.20042—
+2K083175Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom Heparin…Siemens Healthcare Diagnostics20090—
+2K051472Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh CalibratorHyphen Biomed200504