Medical Device Manufacturer · CN , Shenzhen

Shenzhen New Industries Biomedical Engineering Co., Ltd.

5 submissions · 5 cleared · Since 2017
5
Total
5
Cleared
0
Denied

Shenzhen New Industries Biomedical Engineering Co., Ltd. — FDA 510(k) Submissions

Shenzhen New Industries Biomedical Engineering Co., Ltd. has submitted 5 FDA 510(k) premarket notifications since 2017, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Vitamin D, Radioimmunoassay, Thyroid-stimulating Hormone, Radioimmunoassay, Free Thyroxine, System, Test, Human Chorionic Gonadotropin . Use the specialty filter in the sidebar to narrow results.

5 devices
1–5 of 5
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
K232587 · MRG System, Test, Vitamin D · Chemistry
Apr 2024 231d
MAGLUMI 2000 HCG/?-HCG
K192547 · DHA System, Test, Human... · Chemistry
Jan 2020 122d
MAGLUMI 2000 25-OH Vitamin D
K191499 · MRG System, Test, Vitamin D · Chemistry
Aug 2019 56d
MAGLUMI 2000 FT4
K182423 · CEC Radioimmunoassay, Free... · Chemistry
Oct 2018 28d
MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
K162698 · JLW Radioimmunoassay,... · Chemistry
Jul 2017 290d
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