Medical Device Manufacturer · CN , Shenzhen

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

5 submissions · 5 cleared · Since 2017

5

Total

5

Cleared

0

Denied

FDA 510(k) cleared devices by Shenzhen New Industries Biomedical... Chemistry ✕

5 devices

1-5 of 5

Cleared Apr 12, 2024

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay...

Chemistry · 231d

Cleared Jan 17, 2020

MAGLUMI 2000 HCG/ß-HCG

Chemistry · 122d

Cleared Aug 01, 2019

MAGLUMI 2000 25-OH Vitamin D

Chemistry · 56d

Cleared Oct 04, 2018

MAGLUMI 2000 FT4

Chemistry · 28d

Cleared Jul 14, 2017

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Chemistry · 290d