510(k) Report

Devices descending from K952622

2 later devices reach Cryo Check Normal Human Reference Plasma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091284Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control PlasmaAffinity Biologicals, Inc.20090—
+1K022046Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag…Vital Scientific N.V.20020—