510(k) Report

Devices descending from K042731

8 later devices reach Architect CA 125 II Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072939HE4 Eia, Model: 404-10 USFujirebio Diagnostics,Inc.20087—
+2K151378Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsFujirebio Diagnostics,Inc.20150—
+2K103676Fujirebio Diagnostics Tumor Marker ControlFujirebio Diagnostics,Inc.20110—
+2K093957Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54…Fujirebio Diagnostics,Inc.20104—
+3K112624Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5Roche Diagnostics20122—
+3K101809Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc.20100—
+4K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics20161—
+5K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc.20250—