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Shenzhen New Industries Biomedical Engineering Co., Ltd.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories4
Latest FDA decision2024-04-12
TypeNumberDevice NameCodeDateActions
510(k) K232587 MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerMRG2024-04-12 View
510(k) K192547 MAGLUMI 2000 HCG/ß-HCGDHA2020-01-17 View
510(k) K191499 MAGLUMI 2000 25-OH Vitamin DMRG2019-08-01 View
510(k) K182423 MAGLUMI 2000 FT4CEC2018-10-04 View
510(k) K162698 MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerJLW2017-07-14 View
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