Cleared Traditional

LZI Tramadol Enzyme Immunoassay

K201223 · Lin-Zhi International, Inc. · Toxicology
Jun 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K201223 is an FDA 510(k) clearance for the LZI Tramadol 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 June 4, 2020, 29 days after receiving the submission on May 6, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K201223 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2020
Decision Date June 04, 2020
Days to Decision 29 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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