CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup— 510(k) K252118

Name: FDA 510(k) clearance K252118
Creator: U.S. Food and Drug Administration
Published: 2025-08-27

Substantially Equivalent

Hangzhou Clongene Biotech Co., Ltd.

FDA 510(k) clearance K252118 for CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup, Substantially Equivalent on 2025-08-27. Applicant: Hangzhou Clongene Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou Clongene Biotech Co., Ltd.
Product code: Code NFT
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2025-07-07
Decision date: 2025-08-27
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.