FDA 510(k)

ASI Automatizado RPR (rápido reagente plasmático) Teste para Sífilis, para uso no ASI Evolution Automatizado Analisador de Sífilis

Número K: K201438 · 2020-10-21

RequerenteArlington Scientific, Inc. (Asi)

Data da decisão2020-10-21

Código do produtoGMQ

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Arlington Scientific, Inc. (Asi). It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K201438. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer?

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Arlington Scientific, Inc. (Asi). The 510(k) number is K201438.

When did ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer receive FDA 510(k) clearance?

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201438.

Who is the listed applicant for ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer?

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

What is the FDA product code for ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer?

The FDA product code for ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer is GMQ.

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Outros registros que listam Arlington Scientific, Inc. (Asi) como candidato(a)

K182391ASI Automatizado ASI RPR Teste para Sífilis no ASI Evolution K173376ASI Evolution

Dispositivos Relacionados (Código: GMQ)

K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC K182391ASI Automatizado ASI RPR Teste para Sífilis no ASI EvolutionArlington Scientific, Inc. (Asi)K173376ASI EvolutionArlington Scientific, Inc. (Asi)

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