FDA applicant
Shenzhen Dakewe Bio-Engineering Co., Ltd.
FDA records 3 decisions for Shenzhen Dakewe Bio-Engineering Co., Ltd. (Shenzhen, CN) from 2023 to 2024: 3 510(k) clearances. Most are in product codes JSM (Culture Media, Non-Propagating Transport) and QBD (Microbial Nucleic Acid Storage And…). Since 2016 its 510(k)s took a median of 203 days from receipt to decision, against 271 for FDA’s reviews in the same codes and years. 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 Shenzhen Dakewe Bio-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 2023.
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