Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (K222955)
Description
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard by Xenta Biomedical Science Co., Ltd., an FDA 510(k) cleared clinical toxicology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222955
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. Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (K222955) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug T... | Co-Innovation Biotech Co., Ltd. | 2016 |
Trace the full predicate network for K222955
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.