Cleared Traditional

LZI Oxycodone III Enzyme Immunoassay

K202007 · Lin-Zhi International, Inc. · Toxicology
Sep 2020
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K202007 is an FDA 510(k) clearance for the LZI Oxycodone III Enzyme Immunoassay, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 17, 2020, 58 days after receiving the submission on July 21, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K202007 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2020
Decision Date September 17, 2020
Days to Decision 58 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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