510(k) Report

Devices descending from K060373

18 later devices reach Cobas 6000 Series System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics201933
+1K163569Elecsys CMV IgMRoche Diagnostics201702
+1K111188Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack…Roche Diagnostics201204
+1K110726Roche Acetaminophen AssayRoche Diagnostics201101
+1K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—
+1K100853Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp.2010911
+2K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…Roche Diagnostics20260—
+2K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche Diagnostics20260—
+2K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…Roche Diagnostics20220—
+2K132462S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreHitachi Chemical Diagnostics, Inc.20130—
+2K130685Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyHitachi Chemical Diagnostics, Inc.20130—
+2K120945Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…Hitachi Chemical Diagnostics, Inc.20130—
+2K131051Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)Hitachi Chemical Diagnostics, Inc.20130—
+2K131217S Test Reagent Cartridge Total BilirubinHitachi Chemical Diagnostics, Inc.20130—
+2K130870Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA)Hitachi Chemical Diagnostics, Inc.20130—
+2K130141S Test Reagent Cartridge Alp (Alkaline Phosphatase)Hitachi Chemical Diagnostics, Inc.20130—
+2K113809Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)Hitachi Chemical Diagnostics, Inc.20120—
+2K120369Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)Hitachi Chemical Diagnostics, Inc.20120—