510(k) Report

Devices descending from K033908

23 later devices reach N High Sensitivity CRP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH20221—
+1K081294Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), CalibratorsSiemens Healthcare Diagnostics, Inc.200802
+1K071002Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) ReagentBeckman Coulter, Inc.20070—
+1K070626Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) ReagentBeckman Coulter, Inc.20071—
+1K063057Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPDiagnostic Products Corporation20061—
+1K061802Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp…Dade Behring, Inc.20060—
+1K061825Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and…Dade Behring, Inc.20060—
+1K060369Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, DilpakDade Behring, Inc.200611
+1K053603C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsRoche Diagnostics Corp.20062—
+1K042485Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Roche Diagnostics Corp.200471
+1K041799Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17…Ortho-Clinical Diagnostics, Inc.200423
+2K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics20260—
+2K233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc.20240—
+2K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd.20180—
+2K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…Qualigen, Inc.20150—
+2K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories20113—
+2K091052Piccolo C-Reactive Protein (CRP) Test SystemAbaxis, Inc.20100—
+2K071017Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP…Siemens Medical Solutions Diagnostics20070—
+2K062924Stratus CS Acute Care Cardiophase Hscrp TestpakDade Behring, Inc.200601
+2K042838Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance…Ortho-Clinical Diagnostics, Inc.20040—
+3K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics20171—
+3K121558Diazyme Hscrp Poc Test KitDiazyme Laboratories20120—
+4K191993Yumizen C1200 CRPHoriba Abx Sas20190—