510(k) Report

Devices descending from K771346

5 later devices reach CI-Trol Coagulation Controls II & Iii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992279Heparin Control Plasma Level 2Pacific Hemostasis19991—
+1K992278Heparin Control Plasma Level 1Pacific Hemostasis19991—
+1K984130Coagulation Control Level 2 (Abnormal)Pacific Hemostasis19981—
+1K984131Coagulation Control Level 3 (Abnormal)Pacific Hemostasis19981—
+2K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M…Wortham Laboratories, Inc.20070—