510(k) Report

Devices descending from K992680

11 later devices reach Elecsys Parathyroid Hormone Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070709Roche Elecsys PTH Test SystemRoche Diagnostics Corp.20072—
+1K063605ST Aia-Pack Intact PTH AssayTosoh Bioscience, Inc.20070—
+1K063232Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High)…Biokit, S.A.200734
+1K070391Elecsys PTH Test SystemRoche Diagnostics Corp.20070—
+1K061190Access Intact PTH and Calibrators, Models a 16972 and a 16953Beckman Coulter, Inc.200611
+2K231927Elecsys PTH , Elecsys PTH STATRoche Diagnostics20240—
+2K232791Access Intact PTHBeckman Coulter, Inc.202401
+2K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics20230—
+2K121981Advia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics201322
+3K133601Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics, Inc.20141—
+4K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.20170—