510(k) Report

Devices descending from K951595

88 later devices reach Roche Cobas Integra Analyzer, Reagent Cassettes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…Elitechgroup20160—
+1K160570Creatine KinaseRoche Diagnostics Operations (Rdo)201601
+1K081193Cobas Integra 400/800 Bilirubin TotalRoche Diagnostics20090—
+1K071644Online Phenobarbital, Model 03016757190 & 03510620Roche Diagnostics Corp.20070—
+1K063543Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322…Roche Diagnostics Corp.200610—
+1K060773Online TDM ProcainamideRoche Diagnostics Corp.20060—
+1K060738TDM N-AcetylprocainamideRoche Diagnostics Corp.200601
+1K060690Online Valproic AcidRoche Diagnostics Corp.200601
+1K061093Cholinesterase Gen.2 Test SystemRoche Diagnostics Corp.20060—
+1K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.200504
+1K032332Roche Online TDM QuinidineRoche Diagnostics Corp.20040—
+1K033306Preciset Dat Plus II and Cfas Dat Qualitative Plus CalibratorsRoche Diagnostics Corp.20032—
+1K033009Roche Diagnostics Cobas Integra Albumin Gen. 2Roche Diagnostics Corp.200303
+1K033165Preciset Dat Amphetamine Calibrators; Cfas Dat Qualitative Amphetamine CalibratorsRoche Diagnostics Corp.20030—
+1K031902Online TDM CarbamazepineRoche Diagnostics Corp.20031—
+1K031775Preciset Dat Plus I CalibratorsRoche Diagnostics Corp.20032—
+1K031880Ammonia/Ethanol/CO2 Calibrator, Control Normal, Control AbnormalRoche Diagnostics Corp.200303
+1K023296Cobas Integra Online Dat II Cocaine IIRoche Diagnostics Corp.20020—
+1K021512Cobas Integra Online Dat II Methadone IIRoche Diagnostics Corp.20020—
+1K012359Tina-Quant Complement C4 Test SystemRoche Diagnostics Corp.200101
+1K012361Tina-Quant Complement C3C Test SystemRoche Diagnostics Corp.20010—
+1K012393Tina-Quant Transferrin Ver.2Roche Diagnostics Corp.20012—
+1K990595Integra Reagent Cassette for Apolipoprotein BRoche Diagnostics Corp.19991—
+1K983556Abuscreen Online Benz 300 CalibratorsRoche Diagnostic Systems, Inc.19980—
+1K983555Abuscreen Online Benz 200 CalibratorsRoche Diagnostic Systems, Inc.19980—
+1K981897Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas…Roche Diagnostic Systems, Inc.199820—
+1K974695Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with…Roche Diagnostic Systems, Inc.19980—
+1K973284Cobas Integra HDL-Cholesterol DirectRoche Diagnostic Systems, Inc.19970—
+1K972250Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc.1997171
+1K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc.199712
+1K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc.199612
+1K961824Cobas Integra Reagent Cassettes for Albumin, Hbalc and DigoxinRoche Diagnostic Systems, Inc.19961—
+2K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHoriba Abx Sas20200—
+2K151578Carbamazepine Gen 4Roche Diagnostics Operations (Rdo)20150—
+2K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS20140—
+2K131544Cobas C Bilirubin Total Gen.3Roche Diagnostics201312
+2K123965Cobas Integra Bilirubin Direct Gen.2Roche Diagnostics20130—
+2K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—
+2K090939Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical…Roche Diagnostics20090—
+2K073277Roche-Creactive Protein (Latex)Roche Diagnostics Corp.20082—
+2K063766Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model#…Good Biotech Corp.20070—
+2K063744Cobas Integra C 111Rochdiag20076—
+2K062239Glucose HK New Formulation Test SystemRoche Diagnostics Corp.20060—
+2K060853Online TDM TobramycinRoche Diagnostics Corp.200602
+2K060645Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus CalibratorsRoche Diagnostics Corp.20060—
+2K061048Cobas Integra Glucose HK Gen. 3 Test SystemRoche Diagnostics Corp.20061—
+2K033185Cobas Integra Alp Ifcc Gen.2Roche Diagnostics Corp.20033—
+2K031856Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp.200312
+2K031650Ferritin Generation 2Roche Diagnostics Corp.20030—
+2K013207Tina-Quant Apolipoprotein B Ver.2Roche Diagnostics Corp.20010—
+2K003400CRP HS Test SystemRoche Diagnostics Corp.200112—
+2K990992Integra Reagent Cassette for Hemoglobin AlcRoche Diagnostics Corp.19990—
+2K980996Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)Roche Diagnostic Systems, Inc.19989—
+3K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.20260—
+3K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC20180—
+3K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)20171—
+3K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…Elitechgroup20120—
+3K122083Elitech Clinical Systems CK Nac SLElitechgroup20121—
+3K113809Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)Hitachi Chemical Diagnostics, Inc.20120—
+3K113269Elittech Clinical Systems Alp Ifcc SLElitechgroup20110—
+3K110830Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…Elitechgroup201101
+3K092603Cobas Integra Glucose HK Gen 3 AssayRoche Diagnostics20090—
+3K091617QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific20090—
+3K071211Cobas C 111 AnalyzerRoche Diagnostics200713
+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—
+3K031879Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp.20038—
+4K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas20190—
+4K183555GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+4K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup20140—
+4K111960Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…Elitechgroup20110—
+4K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories20113—
+4K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV201104
+4K083444C-Reactive Protein (Latex)Roche Diagnostics Corp.200921
+4K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx200612
+4K053603C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsRoche Diagnostics Corp.20062—
+4K032377Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp.20032—
+5K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics20260—
+5K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—
+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—
+5K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+5K071340Carbon Dioxide (CO2), Scal, Nortrol and AbtrolThermofisher Scientific OY20070—
+5K060295Carbon DioxideAbbott Laboratories200601
+6K191993Yumizen C1200 CRPHoriba Abx Sas20190—