Cleared Traditional

LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS

K113661 · Lin-Zhi International, Inc. · Chemistry
Jan 2012
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K113661 is an FDA 510(k) clearance for the LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE 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 January 23, 2012, 41 days after receiving the submission on December 13, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K113661 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2011
Decision Date January 23, 2012
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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