FDA 510(k)

Alere i Influenza A & B, Kit de Swab de Controle de Influenza A & B Alere i, Alere i Instrumento

Número K: K163266 · 2016-12-21

Data da decisão2016-12-21

Código do produtoOCC

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument 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 2016-12-21 under 510(k) number K163266. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K163266.

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

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument received FDA 510(k) clearance on 2016-12-21, under 510(k) number K163266.

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

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

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

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

K190204ID NOW Influenza A & B 2 K181853Alere BinaxNOW Cartão de Influenza A & B 2, Leitor Alere 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

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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.

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