510(k) Report

Devices descending from K941737

3 later devices reach Specialty Assayed Control-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020878Lyphochek Hemostasis, Models 798, 799Bio-Rad20022—
+2K043451Biophen Normal and Abnormal Control Plasma; Biophen Plasma CalibratorHyphen Biomed20050—
+2K040275Lyphochek Hemostasis ControlBio-Rad20040—