510(k) Report

Devices descending from K971418

21 later devices reach Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083373Immulite 2000 Free T4Siemens Healthcare Diagnostics, Inc.20091—
+1K032525Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC200318—
+2K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc.20160—
+2K041133Modification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC2004178
+3K171642Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, Inc.20170—
+3K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators…Siemens Healthcare Diagnostics, Inc.2015422
+3K122599Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorSiemens Healthcare Diagnostics, Inc.201201
+3K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc.200943
+3K071224Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 CalibratorDade Behring, Inc.200741
+4K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…Siemens Healthcare Diagnostics, Inc.202301
+4K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20171—
+4K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…Siemens Healthcare Diagnostics201708
+4K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4…Siemens Healthcare Diagnostics, Inc.20121—
+4K093645Exl Anem Cal, Model RC640Siemens Healthcare Diagnostics20100—
+4K093318Accelerator ApsAbbott Laboratories201032
+4K093631B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642 and RF644Siemens Healthcare Diagnostics20100—
+5K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20240—
+5K213486GLP systems TrackAbbott Laboratories20221—
+5K133512Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)Siemens Healthcare Diagnostics20140—
+5K121012Flexlab 3.6, Accelerator A3600Inpeco S.P.A.2012033
+6K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories20230—