510(k) Report

Devices descending from K003668

3 later devices reach Autodelfia Neonatal Irt Kit, Model B005-112 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110274Autodelfia Neonatal Irt KitWallac Oy, A Subsidiary of Perkinelmer, Inc.201101
+1K102419GSP Neonatal Irt Kit (3306-001U)Wallac Oy, Subsidiary of Perkinelmer20100—
+1K070889Autodelfia Neonatal Irt L Kit, Model B022-112Wallac OY20080—