Cleared Traditional

ARK Fentanyl II Assay

K200197 · ARK Diagnostics, Inc. · Toxicology
Feb 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K200197 is an FDA 510(k) clearance for the ARK Fentanyl II Assay, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on February 26, 2020, 30 days after receiving the submission on January 27, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K200197 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2020
Decision Date February 26, 2020
Days to Decision 30 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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