510(k) Report

Devices descending from K833892

6 later devices reach Coatest Factor Viii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042576Coatest SP FviiiInstrumentation Laboratory CO20042—
+1K033631Modification to Coatest Factor ViiiInstrumentation Laboratory CO20030—
+1K981038Coamatic Factor ViiiInstrumentation Laboratory CO19981—
+2K193204Cryocheck Chromogenic Factor VIIIPrecision Biologic20201—
+2K052825Visulize Factor Viii Antigen Kit, Model Fviii-AGAffinity Biologicals, Inc.20060—
+3K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.20250—