Cleared Traditional

LZI Methadone II Enzyme Immunoassay

K192433 · Lin-Zhi International, Inc. · Toxicology
Oct 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K192433 is an FDA 510(k) clearance for the LZI Methadone II Enzyme Immunoassay, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 4, 2019, 29 days after receiving the submission on September 5, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K192433 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2019
Decision Date October 04, 2019
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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