510(k) Report

Devices descending from K981752

1 later device reach I-Stat Coagulation Control Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071319I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01…Bio-Rad, Diagnostics Grp.20070—