510(k) Report

Devices descending from K151792

4 later devices reach Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…Siemens Healthcare Diagnostics, Inc.202301
+1K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20171—
+1K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…Siemens Healthcare Diagnostics201708
+2K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20240—