510(k) Report

Devices descending from K931118

5 later devices reach Assess (TM) High Abnormal Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022046Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag…Vital Scientific N.V.20020—
+1K021024Hemosil High Abnormal Control AssayedInstrumentation Laboratory CO200233
+2K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd.20180—
+2K082859Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO20081—
+3K110432Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc.20110—