Cleared Special

LZI Fentanyl III Enzyme Immunoassay

K251634 · Lin-Zhi International, Inc. · Toxicology
Jun 2025
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K251634 is an FDA 510(k) clearance for the LZI Fentanyl III Enzyme Immunoassay, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on June 18, 2025, 20 days after receiving the submission on May 29, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K251634 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2025
Decision Date June 18, 2025
Days to Decision 20 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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