510(k) Report

Devices descending from K905203

5 later devices reach Coagulation Reference Plasma, Normal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041905Hemosil Calibration PlasmaInstrumentation Laboratory CO20044—
+2K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd.20180—
+2K092113Sta - Free PS CalibratorDiagnostica Stago, Inc.20090—
+2K090563Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)Instrumentation Laboratory CO20091—
+3K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc.20100—