FDA applicant
Guangzhou Wondfo Biotech Co., Ltd.
FDA records 43 decisions for Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, MD) from 2005 to 2026: 43 510(k) clearances. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and DKZ (Enzyme Immunoassay, Amphetamine). Since 2016 its 510(k)s took a median of 109 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 56 predicates, 20 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Guangzhou Wondfo Biotech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Guangzhou Wondfo Biotech 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