Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup— 510(k) K252554

Name: FDA 510(k) clearance K252554
Creator: U.S. Food and Drug Administration
Published: 2025-09-12

Substantially Equivalent

Vivachek Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K252554 for Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup, Substantially Equivalent on 2025-09-12. Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
Product code: Code NFT
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2025-08-13
Decision date: 2025-09-12
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.