FDA 510(k)

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

N.º K: K152122 · 2016-06-24

SolicitanteAlfa Scientific Designs, Inc.

Fecha de decisión2016-06-24

Código de productoDKZ

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home 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 2016-06-24 under 510(k) number K152122. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)?

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K152122.

When did Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) receive FDA 510(k) clearance?

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) received FDA 510(k) clearance on 2016-06-24, under 510(k) number K152122.

Who is the listed applicant for Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home 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 Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)?

The FDA product code for Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) is DKZ.

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Otros registros que enlistan a Alfa Scientific Designs, Inc. como solicitante

K262299Instant-View® hCG Combo II Cassette Test K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)K173212Instant-view-PLUS immunochemical Fecal Occult Blood Test

Dispositivos relacionados (Código: DKZ)

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Fuente oficial

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