FDA 510(k)

Instant-view-PLUS immunochemical Fecal Occult Blood Test

Número K: K173212 · 2018-02-15

Data da decisão2018-02-15

Código do produtoKHE

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Instant-view-PLUS immunochemical Fecal Occult Blood Test 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 2018-02-15 under 510(k) number K173212. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Instant-view-PLUS immunochemical Fecal Occult Blood Test?

Instant-view-PLUS immunochemical Fecal Occult Blood Test is a medical device that received FDA 510(k) clearance on 2018-02-15. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K173212.

When did Instant-view-PLUS immunochemical Fecal Occult Blood Test receive FDA 510(k) clearance?

Instant-view-PLUS immunochemical Fecal Occult Blood Test received FDA 510(k) clearance on 2018-02-15, under 510(k) number K173212.

Who is the listed applicant for Instant-view-PLUS immunochemical Fecal Occult Blood Test?

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 immunochemical Fecal Occult Blood Test?

The FDA product code for Instant-view-PLUS immunochemical Fecal Occult Blood Test is KHE.

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

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)K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

Dispositivos Relacionados (Código: KHE)

K170548InSure ONEEnterix, Inc.K171484hema-screen SPECIFIC GoldImmunostics Inc.,K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd.K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc.,

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