510(k) Report

Devices descending from K034007

2 later devices reach Hemosil Factor Viii Deficient Plasma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110237Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO20111—
+2K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.20230—