FDA 510(k)

Alere BinaxNOW Influenza A & B Carte 2, Alere Reader, Alere BinaxNOW Influenza A & B Carte 2 Kit de Swab de Contrôle

Numéro K : K173502 · 2017-12-13

Date de décision2017-12-13

Code produitPSZ

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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 2017-12-13 under 510(k) number K173502. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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 2017-12-13. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K173502.

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 2017-12-13, under 510(k) number K173502.

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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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 K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 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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