Shenzhen New Industries Biomedical Engineering Co., Ltd. - FDA 510(k)...
Recent clearances: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer, MAGLUMI 2000 HCG/ß-HCG, MAGLUMI 2000 25-OH Vitamin D
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen New Industries Biomedical Engineering Co., Ltd. Chemistry ✕
5 devices
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