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Shenzhen New Industries Biomedical Engineering Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerApril 12, 2024
K192547MAGLUMI 2000 HCG/ß-HCGJanuary 17, 2020
K191499MAGLUMI 2000 25-OH Vitamin DAugust 1, 2019
K182423MAGLUMI 2000 FT4October 4, 2018
K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerJuly 14, 2017