510(k) Report

Devices descending from K900411

1 later device reach Factor XI Deficient Plasma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981173Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15 (1.5ML)Precision Biologicals, Inc.19990—