510(k) Report

Devices descending from K843202

3 later devices reach Heparin Calibrator Aca 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