FDA 510(k)

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

N.º K: K171792 · 2017-09-29

Fecha de decisión2017-09-29

Código de productoOCC

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B 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 2017-09-29 under 510(k) number K171792. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit?

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K171792.

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

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit received FDA 510(k) clearance on 2017-09-29, under 510(k) number K171792.

Who is the listed applicant for Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B 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 Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit?

The FDA product code for Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit is OCC.

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

Ver todos los 10 dispositivos →

Dispositivos relacionados (Código: OCC)

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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