FDA 510(k)

Alere BinaxNOW Cartão de Influenza A & B 2, Leitor Alere

Número K: K181853 · 2018-08-08

Data da decisão2018-08-08

Código do produtoPSZ

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is the device name listed in this FDA 510(k) record. The listed applicant is Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K181853. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K181853.

When did Alere BinaxNOW Influenza A & B Card 2, Alere Reader receive FDA 510(k) clearance?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader received FDA 510(k) clearance on 2018-08-08, under 510(k) number K181853.

Who is the listed applicant for Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

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

What is the FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

The FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader is PSZ.

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Outros registros que listam Alere Scarborough, Inc. como candidato(a)

K190204ID NOW Influenza A & B 2 K173653Alere i Strep A 2, Alere i instrumento, Alere i Strep A 2 Control Swab Kit K173932Alere i Influenza A & B, Alere i Estreptococo A, Alere i RSV, Alere i Influenza A & B 2 K173502Alere BinaxNOW Cartão de Influenza A & B 2, Leitor Alere, Kit de Swab de Controle do Alere BinaxNOW Influenza A & B 2 K171792Alere i Influenza A & B 2, Alere i Instrumento, Kit de Swab de Controle de Influenza A & B Alere i K162642Alere BinaxNOW Cartão de Influenza A & B 2, Leitor Alere, Kit de Swab de Controle do Alere BinaxNOW Influenza A & B 2

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