FDA applicant
Shenzhen New Industries Biomedical Engineering Co., Ltd.
FDA records 5 decisions for Shenzhen New Industries Biomedical Engineering Co., Ltd. (Shenzhen, CN) from 2017 to 2024: 5 510(k) clearances. Most are in product codes MRG (System, Test, Vitamin D) and JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). Its devices cite 7 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen New Industries Biomedical Engineering Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
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