510(k) Report

Devices descending from K891094

2 later devices reach Aca (R) Digitoxin (DGTX) Method through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990251DGTX Flex Reagent Cartridge, Model DF36Dade Behring, Inc.19991—
+2K062024Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin…Dade Behring, Inc.200604