FDA applicant
Bioteke Corporation (Wuxi) Co., Ltd.
FDA records 2 decisions for Bioteke Corporation (Wuxi) Co., Ltd. (Wuxi City, CN) from 2022 to 2026: 2 510(k) clearances. Most are in product codes JSM (Culture Media, Non-Propagating Transport) and NFT (Test, Amphetamine, Over The Counter). Its devices cite 3 predicates, 0 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 Bioteke Corporation (Wuxi) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Bioteke Corporation (Wuxi) Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report