510(k) Report

Devices descending from K021024

3 later devices reach Hemosil High Abnormal Control Assayed through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd.20180—
+1K082859Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO20081—
+2K110432Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc.20110—