LZI Fentanyl III Enzyme Immunoassay— 510(k) K251634

Name: FDA 510(k) clearance K251634
Creator: U.S. Food and Drug Administration
Published: 2025-06-18

Substantially Equivalent

Lin-Zhi International, Inc.

FDA 510(k) clearance K251634 for LZI Fentanyl III Enzyme Immunoassay, Substantially Equivalent on 2025-06-18. Applicant: Lin-Zhi International, Inc.. Device class: 2.

Clearance details

Applicant: Lin-Zhi International, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2025-05-29
Decision date: 2025-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJG

view all

K252684 — Labcorp Fentanyl Urine Visual Test2026-01-29
K250741 — Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
K253082 — LZI Buprenorphine II Enzyme Immunoassay2026-01-16
K252520 — SEFRIA Hydrocodone Oral Fluid2025-09-11
K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative +1 more2025-08-15

More clearances from Lin-Zhi International, Inc.

view all

K202007 — LZI Oxycodone III Enzyme Immunoassay2020-09-17
K201938 — LZI Fentanyl II Enzyme Immunoassay2020-08-07
K201223 — LZI Tramadol Enzyme Immunoassay2020-06-04
K192299 — LZI Cotinine II Enzyme Immunoassay2019-11-21
K192433 — LZI Methadone II Enzyme Immunoassay2019-10-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.