510(k) Report

Devices descending from K961481

32 later devices reach Elecsys 2010 Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062581Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemOlympus America, Inc.20060—
+1K061970Elecsys Ige II ImmunoassayRoche Diagnostics20061—
+1K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp.20069—
+1K060373Cobas 6000 Series SystemRoche Diagnostics20061810
+2K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.20220—
+2K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics201933
+2K163569Elecsys CMV IgMRoche Diagnostics201702
+2K151786Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSetRoche Diagnostics20150—
+2K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc.20143—
+2K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4…Siemens Healthcare Diagnostics, Inc.20121—
+2K111188Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack…Roche Diagnostics201204
+2K110726Roche Acetaminophen AssayRoche Diagnostics201101
+2K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—
+2K110579Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 ControlsAbbott Laboratories20111—
+2K100853Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp.2010911
+3K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…Roche Diagnostics20260—
+3K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics20260—
+3K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…Roche Diagnostics20220—
+3K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc.20162—
+3K133512Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)Siemens Healthcare Diagnostics20140—
+3K132462S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreHitachi Chemical Diagnostics, Inc.20130—
+3K130685Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyHitachi Chemical Diagnostics, Inc.20130—
+3K120945Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…Hitachi Chemical Diagnostics, Inc.20130—
+3K131051Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)Hitachi Chemical Diagnostics, Inc.20130—
+3K131217S Test Reagent Cartridge Total BilirubinHitachi Chemical Diagnostics, Inc.20130—
+3K130870Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA)Hitachi Chemical Diagnostics, Inc.20130—
+3K130141S Test Reagent Cartridge Alp (Alkaline Phosphatase)Hitachi Chemical Diagnostics, Inc.20130—
+3K113809Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)Hitachi Chemical Diagnostics, Inc.20120—
+3K121314Architect B12Abbott Laboratories20120—
+3K120369Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)Hitachi Chemical Diagnostics, Inc.20120—
+4K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.20190—
+4K190121Ids SHBGImmunodiagnostic Systems, Ltd.20190—