Cleared Traditional

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

K201442 · Diatron Group · Toxicology

Jul 2020

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K201442 is an FDA 510(k) clearance for the Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Diatron Group (Medley, US). The FDA issued a Cleared decision on July 31, 2020, 60 days after receiving the submission on June 1, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number	K201442 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2020
Decision Date	July 31, 2020
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF