510(k) Report

Devices descending from K900412

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981174Cryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and FDP12-15 (1.5ML)Precision Biologicals, Inc.19990—