510(k) Report

Devices descending from K961432

4 later devices reach Radias Galt Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993536Bio-Rad Coda Neonatal Galt AssayBio-Rad19990—
+1K990827Microplate Neonatal Galt AssayBio-Rad19993—
+2K102643Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc.20110—
+2K090940Spotcheck Blood Spot Control, AssayedAstoria-Pacific, Inc.20090—