510(k) Report

Devices descending from K063232

3 later devices reach Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121981Advia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics201322
+2K133601Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics, Inc.20141—
+3K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.20170—