510(k) Report

Devices descending from K162698

1 later device reach MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20240—