510(k) Report

Devices descending from K820450

4 later devices reach Thromboscreen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964963Lyphochek Coagulation ControlBio-Rad19973—
+2K990858Lypochek Coagulation Control, Model Nos. 787, 788, 789Bio-Rad19992—
+3K012722Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek…Bio-Rad20011—
+4K032611Lyphochek Coagulation Control, Level 4, Model 743Bio-Rad20030—