510(k) Report

Devices descending from K935212

8 later devices reach IL Test Heparin (XA), PN 84699-15 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980242IL Test HeparinInstrumentation Laboratory CO199871
+2K090209Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin ControlsInstrumentation Laboratory CO200945
+2K983178Coamatic HeparinInstrumentation Laboratory CO19981—
+3K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO202222
+3K162540INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator, INNOVANCE (r) Heparin…Siemens Healthcare Diagnostics Prodcts GmbH20170—
+3K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC20170—
+4K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…Siemens Healthcare Diagnostics Products GmbH20240—
+4K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO20231—