FDA 510(k)

AllTest 다중약물 빠른尿液 검사 컵; AllTest 다중약물尿液 검사 컵

K-번호: K250727 · 2025-04-04

결정일2025-04-04

제품 코드NFT

자문 위원회TX

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Hangzhou AllTest Biotech Co., Ltd.를 신청인으로 등재한 기타 기록

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