Cleared Traditional

ARK Hydrocodone Assay

K231752 · ARK Diagnostics, Inc. · Chemistry
Nov 2023
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K231752 is an FDA 510(k) clearance for the ARK Hydrocodone 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 November 9, 2023, 147 days after receiving the submission on June 15, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K231752 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2023
Decision Date November 09, 2023
Days to Decision 147 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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