FDA 510(k)

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

N.º K: K162642 · 2017-04-10

Fecha de decisión2017-04-10

Código de productoPSZ

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit 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 2017-04-10 under 510(k) number K162642. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K162642.

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

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit received FDA 510(k) clearance on 2017-04-10, under 510(k) number K162642.

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

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, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit?

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

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Otros registros que enlistan a Alere Scarborough, Inc. como solicitante

K190204ID NOW Influenza A & B 2 K181853Alere BinaxNOW Influenza A & B Tarjeta 2, Alere Reader K173653Alere i Estreptococo A 2, Alere i instrumento, Alere i Estreptococo 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 Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

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