FDA 510(k)

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

Numéro K : K173932 · 2018-01-26

Date de décision2018-01-26

Code produitOCC

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 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 2018-01-26 under 510(k) number K173932. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2?

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K173932.

When did Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 receive FDA 510(k) clearance?

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 received FDA 510(k) clearance on 2018-01-26, under 510(k) number K173932.

Who is the listed applicant for Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2?

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 Strep A, Alere i RSV, Alere i Influenza A & B 2?

The FDA product code for Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 is OCC.

Essais cliniques associés

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Autres dossiers indiquant Alere Scarborough, Inc. en tant que demandeur

K190204ID NOW Influenza A & B 2 K181853Alere BinaxNOW Influenza A & B Carte 2, Alere Reader K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit K173502Alere BinaxNOW Influenza A & B Carte 2, Alere Reader, Alere BinaxNOW Influenza A & B Carte 2 Kit de Swab de Contrôle K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit K162642Alere BinaxNOW Influenza A & B Carte 2, Alere Reader, Alere BinaxNOW Influenza A & B Carte 2 Kit de Swab de Contrôle

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Dispositifs connexes (Code : 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.

Source officielle

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