510(k) Report

Devices descending from K991498

1 later device reach Accuwell Total Galactose, Model 6010-Egal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121101Spotcheck Neonatal Total Galactose Microplate Reagent KitAstoria-Pacific, Inc.20130—