510(k) Report

Devices descending from K895880

22 later devices reach Pancreatic a-Amylase Eps through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051447Sentinel Pancreatic AmylaseSentinel Ch. Srl20060—
+1K981897Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas…Roche Diagnostic Systems, Inc.199820—
+2K073277Roche-Creactive Protein (Latex)Roche Diagnostics Corp.20082—
+2K033185Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp.20033—
+2K003400CRP HS Test SystemRoche Diagnostics Corp.200112—
+3K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC20180—
+3K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)20171—
+3K113809Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)Hitachi Chemical Diagnostics, Inc.20120—
+3K113269Elittech Clinical Systems Alp Ifcc SLElitechgroup20110—
+3K042485Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Roche Diagnostics Corp.200471
+3K032336Tina-Quant CRP (Latex)Roche Diagnostics Corp.20033—
+4K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas20190—
+4K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories20113—
+4K083444C-Reactive Protein (Latex)Roche Diagnostics Corp.200921
+4K053603C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsRoche Diagnostics Corp.20062—
+5K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics20260—
+5K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)20200—
+5K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd.20180—
+5K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics20171—
+5K161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group201701
+5K121558Diazyme Hscrp Poc Test KitDiazyme Laboratories20120—
+6K191993Yumizen C1200 CRPHoriba Abx Sas20190—