Cleared Traditional

LZI Cotinine II Enzyme Immunoassay

K192299 · Lin-Zhi International, Inc. · Toxicology
Nov 2019
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K192299 is an FDA 510(k) clearance for the LZI Cotinine II Enzyme Immunoassay, a Enzyme Immunoassay, Nicotine And Nicotine Metabolites (Class I — General Controls, product code MKU), submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on November 21, 2019, 90 days after receiving the submission on August 23, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3220.

Submission Details

510(k) Number K192299 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2019
Decision Date November 21, 2019
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code MKU — Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3220

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