Cleared Traditional

LZI Fentanyl II Enzyme Immunoassay

K201938 · Lin-Zhi International, Inc. · Chemistry
Aug 2020
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K201938 is an FDA 510(k) clearance for the LZI Fentanyl II 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 August 7, 2020, 25 days after receiving the submission on July 13, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K201938 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2020
Decision Date August 07, 2020
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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