FDA 510(k)

ID NOW Influenza A & B 2

Numéro K : K190204 · 2019-03-18

Date de décision2019-03-18

Code produitOZE

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

ID NOW 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 2019-03-18 under 510(k) number K190204. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ID NOW Influenza A & B 2?

ID NOW Influenza A & B 2 is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K190204.

When did ID NOW Influenza A & B 2 receive FDA 510(k) clearance?

ID NOW Influenza A & B 2 received FDA 510(k) clearance on 2019-03-18, under 510(k) number K190204.

Who is the listed applicant for ID NOW 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 ID NOW Influenza A & B 2?

The FDA product code for ID NOW Influenza A & B 2 is OZE.

Essais cliniques associés

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

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 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

Voir tous les 10 dispositifs →

Dispositifs connexes (Code : OZE)

K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)Centers for Disease Control and Prevention K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)Centers for Disease Control and Prevention K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)Centers for Disease Control and Prevention K230236Lyra Influenza A+B AssayQuidel Corporation K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitCenters for Disease Control and Prevention

Source officielle

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