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

2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification

CENTERS FOR DISEASE CONTROL AND PREVENTION

The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Cdc Influenza 2009 A(h1n1)pdm Real-time Rt-pcr Panel.

Pre-market Notification Details

Device IDK101564
510k NumberK101564
Device Name:CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
Classification2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Applicant CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD., N.E. MAILSTOP C-12 Atlanta,  GA  30333
ContactHye-joo Kim
CorrespondentHye-joo Kim
CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD., N.E. MAILSTOP C-12 Atlanta,  GA  30333
Product CodeOQW  
CFR Regulation Number866.3332 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-04
Decision Date2010-06-22
Summary:summary

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