Cleared Traditional

ARK Fentanyl Assay

K180427 · ARK Diagnostics, Inc. · Toxicology
Jun 2018
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K180427 is an FDA 510(k) clearance for the ARK Fentanyl 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 June 6, 2018, 110 days after receiving the submission on February 16, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K180427 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2018
Decision Date June 06, 2018
Days to Decision 110 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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