510(k) Report

Devices descending from K020878

2 later devices reach Lyphochek Hemostasis, Models 798, 799 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043451Biophen Normal and Abnormal Control Plasma; Biophen Plasma CalibratorHyphen Biomed20050—
+1K040275Lyphochek Hemostasis ControlBio-Rad20040—