510(k) Report

Devices descending from K990774

5 later devices reach Abbott Architect Cea through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222251B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QCB.R.A.H.M.S GmbH, Part of Thermo Fisher20230—
+1K100831Cyfra 21-1 Eia Model 211-10Fujirebio Diagnostics,Inc.20113—
+2K202852DiviTum TKaBiovica International AB20220—
+2K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics20161—
+3K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc.20250—