510(k) Report

Devices descending from K083844

9 later devices reach Advia Centaur TSH3-Ultra Method through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.20241—
+1K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20171—
+1K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator…Sysmex America, Inc.20160—
+1K150403ADVIA Centaur TSH3-UltraSiemens Healthcare Diagnostics, Inc.201571
+2K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.20260—
+2K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20240—
+2K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators…Siemens Healthcare Diagnostics, Inc.2015422
+3K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…Siemens Healthcare Diagnostics, Inc.202301
+3K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…Siemens Healthcare Diagnostics201708