510(k) Report

Devices descending from K003400

12 later devices reach CRP HS Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042485Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Roche Diagnostics Corp.200471
+1K032336Tina-Quant CRP (Latex)Roche Diagnostics Corp.20033—
+2K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories20113—
+2K083444C-Reactive Protein (Latex)Roche Diagnostics Corp.200921
+2K053603C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsRoche Diagnostics Corp.20062—
+3K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics20260—
+3K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)20200—
+3K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd.20180—
+3K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics20171—
+3K161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group201701
+3K121558Diazyme Hscrp Poc Test KitDiazyme Laboratories20120—
+4K191993Yumizen C1200 CRPHoriba Abx Sas20190—