FDA 510(k)

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup

Numéro K : K250727 · 2025-04-04

DemandeurHangzhou AllTest Biotech Co., Ltd.

Date de décision2025-04-04

Code produitNFT

Comité consultatifTX

DécisionSubstantially Equivalent

Résumé du dispositif

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K250727. 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 AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup?

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K250727.

When did AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup receive FDA 510(k) clearance?

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup received FDA 510(k) clearance on 2025-04-04, under 510(k) number K250727.

Who is the listed applicant for AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup?

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

What is the FDA product code for AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup?

The FDA product code for AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup is NFT.

Essais cliniques associés

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Dispositifs connexes (Code : NFT)

K261409BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd.K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLC K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLC K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.

Source officielle

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