510(k) Report

Devices descending from K981897

20 later devices reach Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073277Roche-Creactive Protein (Latex)Roche Diagnostics Corp.20082—
+1K033185Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp.20033—
+1K003400CRP HS Test SystemRoche Diagnostics Corp.200112—
+2K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC20180—
+2K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)20171—
+2K113809Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)Hitachi Chemical Diagnostics, Inc.20120—
+2K113269Elittech Clinical Systems Alp Ifcc SLElitechgroup20110—
+2K042485Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Roche Diagnostics Corp.200471
+2K032336Tina-Quant CRP (Latex)Roche Diagnostics Corp.20033—
+3K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas20190—
+3K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories20113—
+3K083444C-Reactive Protein (Latex)Roche Diagnostics Corp.200921
+3K053603C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsRoche Diagnostics Corp.20062—
+4K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics20260—
+4K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)20200—
+4K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd.20180—
+4K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics20171—
+4K161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group201701
+4K121558Diazyme Hscrp Poc Test KitDiazyme Laboratories20120—
+5K191993Yumizen C1200 CRPHoriba Abx Sas20190—