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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
510(k) Number K123905
Device Name CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 clifton rd. ne (ms c-18)
atlanta,  GA  30333
Applicant Contact hye-joo kim, pharm. d
Correspondent
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 clifton rd. ne (ms c-18)
atlanta,  GA  30333
Correspodent Contact hye-joo kim, pharm. d
Regulation Number866.3332
Classification Product Code
OQW  
Subsequent Product Codes
NSU   NXD   OEP  
Date Received12/19/2012
Decision Date 01/14/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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