Cleared Traditional

ARK Tramadol Assay

K182280 · ARK Diagnostics, Inc. · Toxicology
Dec 2018
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K182280 is an FDA 510(k) clearance for the ARK Tramadol 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 December 10, 2018, 110 days after receiving the submission on August 22, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K182280 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2018
Decision Date December 10, 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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