510(k) Report

Devices descending from K090209

4 later devices reach Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO202222
+1K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC20170—
+2K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…Siemens Healthcare Diagnostics Products GmbH20240—
+2K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO20231—