510(k) Report

Devices descending from K953239

41 later devices reach Boehringer Mannheim/Hitachi 917 Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072018BS-200 Chemistry Analyzer, Mode BS-200Shenzhen Mindray Bio-Medical Electronics Co., Ltd.200831
+1K060373Cobas 6000 Series SystemRoche Diagnostics20061810
+1K053165Ise Indirect NA, K, CL for Gen.2Roche Diagnostics Corp.20051—
+1K041627Cystatin C Immunoparticles, Control Set, CalibratorDako A/S20048—
+1K990092Avl Omni Modular AnalyzerAvl Scientific Corp.199974
+2K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics201933
+2K163569Elecsys CMV IgMRoche Diagnostics201702
+2K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+2K132418Cobas C 501 Ise Indirect NA, K, CL for Gen. 2Roche Diagnostics20130—
+2K121588Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3Randox Laboratories, Ltd.20120—
+2K111188Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack…Roche Diagnostics201204
+2K112377BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.20121—
+2K110726Roche Acetaminophen AssayRoche Diagnostics201101
+2K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—
+2K100853Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp.2010911
+2K080811Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control…Roche Diagnostics Corp.20085—
+2K063647Cystatin C Antiserum, Calibrator, Control and Control HighThermo Electron OY20070—
+2K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.200504
+2K032311Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp.200319
+2K013373Omni C AnalyzerRoche Diagnostics Corp.200121
+2K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992—
+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—
+3K140690BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.20140—
+3K141143Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C…Roche Diagnostics20144—
+3K132462S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreHitachi Chemical Diagnostics, Inc.20130—
+3K131126Opti Cca-TS2Opti Medical Systems, Inc.20131—
+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—
+3K120369Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)Hitachi Chemical Diagnostics, Inc.20120—
+4K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+4K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH20171—
+4K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo)20161—
+5K242585Cystatin CSENTINEL CH. SpA20250—
+5K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc.20180—