510(k) Report

Devices descending from K864271

6 later devices reach IL Test 84673-30 Chromogenics Control Plasma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040359Hemosil Special Test Controls Level 1 & 2Instrumentation Laboratory CO20040—
+1K021024Hemosil High Abnormal Control AssayedInstrumentation Laboratory CO200233
+1K021022Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed)Instrumentation Laboratory CO200223
+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—