Cleared Traditional

LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS

K131652 · Lin-Zhi International, Inc. · Toxicology
Mar 2014
Decision
289d
Days
Class 2
Risk

About This 510(k) Submission

K131652 is an FDA 510(k) clearance for the LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 21, 2014, 289 days after receiving the submission on June 5, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K131652 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2013
Decision Date March 21, 2014
Days to Decision 289 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAF — Gas Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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