FDA 510(k)

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

Número K: K232597 · 2024-01-09

RequerenteHangzhou Laihe Biotech Co., Ltd.

Data da decisão2024-01-09

Código do produtoDJG

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) 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 2024-01-09 under 510(k) number K232597. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)?

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) is a medical device that received FDA 510(k) clearance on 2024-01-09. The listed applicant is Hangzhou Laihe Biotech Co., Ltd.. The 510(k) number is K232597.

When did LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) receive FDA 510(k) clearance?

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) received FDA 510(k) clearance on 2024-01-09, under 510(k) number K232597.

Who is the listed applicant for LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)?

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® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)?

The FDA product code for LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) is DJG.

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

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