Cleared Traditional

LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS

K133710 · Lin-Zhi International, Inc. · Toxicology
Feb 2014
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K133710 is an FDA 510(k) clearance for the LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 21, 2014, 79 days after receiving the submission on December 4, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K133710 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2013
Decision Date February 21, 2014
Days to Decision 79 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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