510(k) Report

Devices descending from K071649

2 later devices reach Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133652GSP Neonatal Total Galactose KitWallac Oy, A Subsidiary of Perkinelmer, Inc.20141—
+2K190335GSP Neonatal Total Galactose kitPerkinelmer, Inc.20190—