510(k) Report

Devices descending from K915083

11 later devices reach Coamate (R) Antithrombin Chromogenic Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043007Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105Hyphen Biomed20050—
+1K980499IL Test AntithrombinInstrumentation Laboratory CO19989—
+2K070301Hemosil AntithrombinInstrumentation Laboratory CO20070—
+2K033775Hemosil Liquid Antithrombin XLInstrumentation Laboratory CO20042—
+2K022195Coamatic at-400Instrumentation Laboratory CO20022—
+2K994238IL Test Liquid AntithrombinInstrumentation Laboratory CO20004—
+3K062431Hemosil Liquid AntithrombinInstrumentation Laboratory CO20061—
+3K023991Chromocheck Antithrombin 25; Chromocheck Antithrombin 50Precision Biologic20031—
+3K022550Coamatic LR Antithrombin, Note: LR=Liquid ReagentsInstrumentation Laboratory CO20020—
+4K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd.20180—
+4K050448Chromopep PC, Chromopep at, Models 2.5 and 5Horiba Abx20050—