Cleared Traditional

ARK EDDP Assay

K182779 · ARK Diagnostics, Inc. · Toxicology
Nov 2018
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K182779 is an FDA 510(k) clearance for the ARK EDDP Assay, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on November 21, 2018, 51 days after receiving the submission on October 1, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K182779 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2018
Decision Date November 21, 2018
Days to Decision 51 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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