FDA applicant
Hangzhou Clongene Biotech Co., Ltd.
FDA records 9 decisions for Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN) from 2016 to 2026: 9 510(k) clearances. Most are in product codes NGL (Test, Opiates, Over The Counter) and LDJ (Enzyme Immunoassay, Cannabinoids). Since 2016 its 510(k)s took a median of 52 days from receipt to decision, against 45 for FDA’s reviews in the same codes and years. Its devices cite 9 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 Hangzhou Clongene Biotech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Hangzhou Clongene 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