510(k) Report

Devices descending from K041133

17 later devices reach Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer through their predicates, nearest generation first.

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