FDA 510(k)

INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)

Número K: K173303 · 2018-02-23

Data da decisão2018-02-23

Código do produtoDKZ

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K173303. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)?

INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K173303.

When did INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) receive FDA 510(k) clearance?

INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) received FDA 510(k) clearance on 2018-02-23, under 510(k) number K173303.

Who is the listed applicant for INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)?

The FDA 510(k) record lists Alfa Scientific Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)?

The FDA product code for INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) is DKZ.

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Outros registros que listam Alfa Scientific Designs, Inc. como candidato(a)

K262299Instant-View® hCG Combo II Cassette Test K173212Instant-view-PLUS immunochemical Fecal Occult Blood Test K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

Dispositivos Relacionados (Código: DKZ)

K240670DRI Ecstasy Plus AssayMicrogenics Corporation K233019Cup de Teste Rápido de Multi-Drogas AllTest; Painel de Teste Rápido de Multi-Drogas AllTest; Cup de Teste Rápido de Multi-Drogas AllTest Rx; Painel de Teste Rápido de Multi-Drogas AllTest RxHangzhou AllTest Biotech Co., Ltd.K231137Copo de Teste de Drogas Xenta, Cartão de Teste de Drogas XentaXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas Medical K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.

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