510(k) Report

Devices descending from K042485

7 later devices reach Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories20113—
+1K053603C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsRoche Diagnostics Corp.20062—
+2K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics20260—
+2K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd.20180—
+2K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics20171—
+2K121558Diazyme Hscrp Poc Test KitDiazyme Laboratories20120—
+3K191993Yumizen C1200 CRPHoriba Abx Sas20190—