510(k) Report

Devices descending from K935047

6 later devices reach Auto Delfia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090846GSP Instrument and GSP Neonatal HTSH KitPerkinelmer, Inc.200904
+1K042425Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY20044—
+2K081922Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY20091—
+2K060452Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-EcahNeo-Genesis20070—
+2K050960Modification to: Autodelfia Neonatal 17A-OH-Progesterone L KitWallac OY20050—
+3K100682GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001UWallac OY20100—