Cleared Traditional

AllTest Fentanyl Rapid Test (Urine)

K231698 · Hangzhou AllTest Biotech Co., Ltd. · Toxicology
Jul 2023
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K231698 is an FDA 510(k) clearance for the AllTest Fentanyl Rapid Test (Urine), a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 31, 2023, 49 days after receiving the submission on June 12, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K231698 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2023
Decision Date July 31, 2023
Days to Decision 49 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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