Cleared Traditional

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

K182123 · Advin Biotech, Inc. · Toxicology
Mar 2019
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K182123 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 March 29, 2019, 235 days after receiving the submission on August 6, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K182123 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2018
Decision Date March 29, 2019
Days to Decision 235 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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