FDA 510(k)

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

Número K: K240287 · 2025-03-18

RequerenteHangzhou Laihe Biotech Co., Ltd.

Data da decisão2025-03-18

Código do produtoDJC

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Hangzhou Laihe Biotech Co., Ltd. como candidato(a)

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)

Dispositivos Relacionados (Código: DJC)

Fonte oficial

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