510(k) Report

Devices descending from K160571

1 later device reach cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173909Dimension Hemoglobin A1c AssaySiemens Healthcare Diagnostics, Inc.20180—