Cleared Traditional

LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls

K141320 · Lin-Zhi International, Inc. · Toxicology
May 2015
Decision
373d
Days
Class 2
Risk

About This 510(k) Submission

K141320 is an FDA 510(k) clearance for the LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 28, 2015, 373 days after receiving the submission on May 20, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K141320 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2014
Decision Date May 28, 2015
Days to Decision 373 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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