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FDA 510(k)

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup

K-Number: K252554 · 2025-09-12

ApplicantVivachek Biotech (Hangzhou) Co., Ltd.
Decision Date2025-09-12
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup is a medical device manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-12 under approval number K252554. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup?

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K252554.

When was Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup approved by the FDA?

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup received FDA 510(k) clearance on 2025-09-12, under approval number K252554.

What company makes Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup?

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup is manufactured by Vivachek Biotech (Hangzhou) Co., Ltd..

What is the FDA product code for Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup?

The FDA product code for Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup is NFT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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