CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (K252118)
Description
CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup by Hangzhou Clongene Biotech Co., Ltd., an FDA 510(k) cleared clinical toxicology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252118
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (K252118) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug... | Hangzhou AllTest Biotech Co., Ltd. | 2025 |
Trace the full predicate network for K252118
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.