FDA 510(k)

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

K-번호: K240287 · 2025-03-18

결정일2025-03-18

제품 코드DJC

자문 위원회TX

결정Substantially Equivalent

기기 요약

LYHER® Oral fluid Multi-Drug Test Kit (Cube) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Laihe Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K240287. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LYHER® Oral fluid Multi-Drug Test Kit (Cube)?

LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Hangzhou Laihe Biotech Co., Ltd.. The 510(k) number is K240287.

When did LYHER® Oral fluid Multi-Drug Test Kit (Cube) receive FDA 510(k) clearance?

LYHER® Oral fluid Multi-Drug Test Kit (Cube) received FDA 510(k) clearance on 2025-03-18, under 510(k) number K240287.

Who is the listed applicant for LYHER® Oral fluid Multi-Drug Test Kit (Cube)?

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

What is the FDA product code for LYHER® Oral fluid Multi-Drug Test Kit (Cube)?

The FDA product code for LYHER® Oral fluid Multi-Drug Test Kit (Cube) is DJC.

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

K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)K232597LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

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