Cleared Traditional

LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS

K131653 · Lin-Zhi International, Inc. · Toxicology
Feb 2014
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K131653 is an FDA 510(k) clearance for the LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 4, 2014, 244 days after receiving the submission on June 5, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K131653 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2013
Decision Date February 04, 2014
Days to Decision 244 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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