Class Class II
LZI Fentanyl III Enzyme Immunoassay (K251634)
Description
LZI Fentanyl III Enzyme Immunoassay by Lin-Zhi International, Inc., an FDA 510(k) cleared clinical toxicology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251634
Clearance Date2025-06-18
Clearance TypeSpecial
Product CodeDJG
Regulation Number862.3650
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251634
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. LZI Fentanyl III Enzyme Immunoassay (K251634) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201938 | LZI Fentanyl II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020 |
Trace the full predicate network for K251634
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.