510(k) Report

Devices descending from K150678

1 later device reach Sysmex Automated Blood Coagulation Analyzer CS-5100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.20250—