510(k) Report

Devices descending from K042576

2 later devices reach Coatest SP Fviii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193204Cryocheck Chromogenic Factor VIIIPrecision Biologic20201—
+2K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.20250—