Shenzhen New Industries Biomedical Engineering Co., Ltd. - FDA 510(k)...
5
Total
5
Cleared
0
Denied
Shenzhen New Industries Biomedical Engineering Co., Ltd. has 5 FDA 510(k) cleared medical devices. Based in Shenzhen, CN.
Latest FDA clearance: Apr 2024. Active since 2017. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by LSI International, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Shenzhen New Industries Biomedical Engineering Co., Ltd.
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