Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx— 510(k) K222667

Name: FDA 510(k) clearance K222667
Creator: U.S. Food and Drug Administration
Published: 2022-11-10

Substantially Equivalent

Vivachek Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K222667 for Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx, Substantially Equivalent on 2022-11-10. 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: 2022-09-06
Decision date: 2022-11-10
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.