510(k) Report

Devices descending from K990654

3 later devices reach Quantase Total Galactose Screening Assay 500 Test Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071649Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110BWallac OY200823
+2K133652GSP Neonatal Total Galactose KitWallac Oy, A Subsidiary of Perkinelmer, Inc.20141—
+3K190335GSP Neonatal Total Galactose kitPerkinelmer, Inc.20190—