Cleared Traditional

LZI Fentanyl Enzyme Immunoassay

K181159 · Lin-Zhi International, Inc. · Toxicology
Dec 2018
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K181159 is an FDA 510(k) clearance for the LZI Fentanyl 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 December 3, 2018, 216 days after receiving the submission on May 1, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K181159 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2018
Decision Date December 03, 2018
Days to Decision 216 days
Submission Type Traditional
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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