510(k) Report

Devices descending from K053075

3 later devices reach N Antisera to Human Transferrin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182095Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo)20180—
+1K081299Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1…Siemens Healthcare Diagnostics, Inc.20080—
+1K063322Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control…Dade Behring, Inc.20070—