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FDA 510(k)

CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup

K-Number: K252118 · 2025-08-27

ApplicantHangzhou Clongene Biotech Co., Ltd.
Decision Date2025-08-27
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup is a medical device manufactured by Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-08-27 under approval number K252118. 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 CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup?

CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup is a medical device that received FDA 510(k) clearance on 2025-08-27. It is manufactured by Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K252118.

When was CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup approved by the FDA?

CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup received FDA 510(k) clearance on 2025-08-27, under approval number K252118.

What company makes CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup?

CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup is manufactured by Hangzhou Clongene Biotech Co., Ltd..

What is the FDA product code for CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup?

The FDA product code for CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy 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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