510(k) Report

Devices descending from K893524

4 later devices reach Factor IX Deficient Plasma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031829Hemosil Factor IX Deficient PlasmaInstrumentation Laboratory CO20032—
+1K961929Factor Deficient PlasmaUniversal Reagents, Inc.19960—
+2K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company20230—
+2K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.20220—