510(k) Report

Devices descending from K053603

2 later devices reach C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics20260—
+1K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd.20180—