510(k) Report

Devices descending from K980242

7 later devices reach IL Test Heparin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090209Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin ControlsInstrumentation Laboratory CO200945
+1K983178Coamatic HeparinInstrumentation Laboratory CO19981—
+2K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO202222
+2K162540INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator, INNOVANCE (r) Heparin…Siemens Healthcare Diagnostics Prodcts GmbH20170—
+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—