AllTest Fentanyl Rapid Test (Urine)— 510(k) K231698

Name: FDA 510(k) clearance K231698
Creator: U.S. Food and Drug Administration
Published: 2023-07-31

Substantially Equivalent

Hangzhou AllTest Biotech Co., Ltd.

FDA 510(k) clearance K231698 for AllTest Fentanyl Rapid Test (Urine), Substantially Equivalent on 2023-07-31. Applicant: Hangzhou AllTest Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou AllTest Biotech Co., Ltd.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2023-06-12
Decision date: 2023-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.