510(k) Report

Devices descending from K032564

1 later device reach Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model DF111 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062024Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin…Dade Behring, Inc.200604