510(k) Report

Devices descending from K030965

7 later devices reach Control Plasma LMW Heparin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090209Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin ControlsInstrumentation Laboratory CO200945
+1K083159Berichrom Heparin LMW Calibrator, Berichrom Heparin LMW Control 1, and Berichrom Heparin…Siemens Healthcare Diagnostics20090—
+1K051472Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh CalibratorHyphen Biomed200504
+2K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO202222
+2K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC20170—
+3K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…Siemens Healthcare Diagnostics Products GmbH20240—
+3K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO20231—