510(k) Report

Devices descending from K990827

3 later devices reach Microplate Neonatal Galt Assay through their predicates, nearest generation first.

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