510(k) Report

Devices descending from K031829

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company20230—
+1K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.20220—