FDA 510(k)

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

Numéro K : K252118 · 2025-08-27

DemandeurHangzhou Clongene Biotech Co., Ltd.

Date de décision2025-08-27

Code produitNFT

Comité consultatifTX

DécisionSubstantially Equivalent

Résumé du dispositif

CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K252118. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K252118.

When did CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup receive FDA 510(k) clearance?

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

Who is the listed applicant for CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup?

The FDA 510(k) record lists Hangzhou Clongene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Source officielle

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