AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (K252259)
Description
AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup by Assure Tech., LLC, an FDA 510(k) cleared clinical toxicology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252259
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. AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (K252259) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; Ass... | Assure Tech., LLC | 2025 |
Trace the full predicate network for K252259
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.