FDA 510(k)

Alere i Estreptococo A 2, Alere i instrumento, Alere i Estreptococo A 2 Control Swab Kit

N.º K: K173653 · 2018-05-02

Fecha de decisión2018-05-02

Código de productoPGX

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Alere i Strep A 2, Alere i instrument, Alere i Strep A 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 2018-05-02 under 510(k) number K173653. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit?

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit is a medical device that received FDA 510(k) clearance on 2018-05-02. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K173653.

When did Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit receive FDA 510(k) clearance?

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit received FDA 510(k) clearance on 2018-05-02, under 510(k) number K173653.

Who is the listed applicant for Alere i Strep A 2, Alere i instrument, Alere i Strep A 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 i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit?

The FDA product code for Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit is PGX.

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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 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 K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

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Dispositivos relacionados (Código: PGX)

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Fuente oficial

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