FDA applicant
Hangzhou AllTest Biotech Co., Ltd.
FDA records 14 decisions for Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN) from 2019 to 2026: 14 510(k) clearances. Most are in product codes NFT (Test, Amphetamine, Over The Counter) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Since 2016 its 510(k)s took a median of 54 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 6 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 Hangzhou AllTest Biotech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Hangzhou AllTest 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