Cleared Traditional

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

K201494 · Advin Biotech, Inc. · Toxicology
Sep 2020
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K201494 is an FDA 510(k) clearance for the ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Advin Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on September 17, 2020, 104 days after receiving the submission on June 5, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K201494 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2020
Decision Date September 17, 2020
Days to Decision 104 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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