CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC 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 Human Influenza Virus Real-time Rt-pcr Diagnostic Panel.

Pre-market Notification Details

Device IDK130551
510k NumberK130551
Device Name:CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC 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-18 Atlanta,  GA  30333
ContactHye-joo Kim, Pharm. D.
CorrespondentHye-joo Kim, Pharm. D.
CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD., N.E. MAILSTOP C-18 Atlanta,  GA  30333
Product CodeOQW  
Subsequent Product CodeNSU
Subsequent Product CodeNXD
Subsequent Product CodeOEP
CFR Regulation Number866.3332 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-04
Decision Date2013-05-22
Summary:summary

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