510(k) Report

Devices descending from K011235

9 later devices reach Sysmex Automated Coagulation Analyzer / Model # CA-1500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172286Automated Blood Coagulation Analyzer CS-2500Siemens Healthcare Diagnostic Products GmbH20170—
+1K172333Sysmex CS-5100Siemens Healthcare Diagnostics Products GmbH20170—
+1K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH20160—
+1K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH20160—
+1K161317Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH20160—
+1K161312Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH20160—
+1K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH20160—
+1K150678Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostic Products GmbH20161—
+2K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.20250—