510(k) Report

Devices descending from K893525

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K034007Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO20042—
+1K990046Pacific Hemostasis Immunodepleted Factor Viii Deficient PlasmaPacific Hemostasis19990—
+1K961929Factor Deficient PlasmaUniversal Reagents, Inc.19960—
+2K110237Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO20111—
+3K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.20230—