FDA 510(k)

CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL

K-Number: K101564 · 2010-06-22

ApplicantCenters for Disease Control and Prevention

Decision Date2010-06-22

Product CodeOQW

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2010-06-22 under 510(k) number K101564. The device is classified under product code OQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL?

CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL is a medical device that received FDA 510(k) clearance on 2010-06-22. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K101564.

When did CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL receive FDA 510(k) clearance?

CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL received FDA 510(k) clearance on 2010-06-22, under 510(k) number K101564.

Who is the listed applicant for CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL?

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

What is the FDA product code for CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL?

The FDA product code for CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL is OQW.

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Other records listing Centers for Disease Control and Prevention as applicant

K260812Francisella tularensis Real-time PCR Assay K252072Francisella tularensis Real-time PCR assay 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)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)K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

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Related Devices (Code: OQW)

K132237PRODESSE PROFAST+ ASSAYGen-Probe Prodesse, Inc.K130551CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention K123905CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention K120911XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)Cepheid K111778JBAIDS INFLUENZA A SUBTYPING KITU.S Army Medical Materiel Development Activity K111507CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and Prevention

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.