FDA 510(k)

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

Numéro K : K161556 · 2016-06-30

DemandeurCenters For Disease Control and Prevention (CDC)

Date de décision2016-06-30

Code produitOZE

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit is the device name listed in this FDA 510(k) record. The listed applicant is Centers For Disease Control and Prevention (CDC). It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K161556. 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 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit?

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Centers For Disease Control and Prevention (CDC). The 510(k) number is K161556.

When did CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit receive FDA 510(k) clearance?

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit received FDA 510(k) clearance on 2016-06-30, under 510(k) number K161556.

Who is the listed applicant for CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit?

The FDA 510(k) record lists Centers For Disease Control and Prevention (CDC) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit?

The FDA product code for CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit is OZE.

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Autres dossiers indiquant Centers For Disease Control and Prevention (CDC) en tant que demandeur

K181736CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,K170940Rickettsia Real-time PCR Assay

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

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