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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 K130551
Device Name CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON RD., N.E.
MAILSTOP C-18
ATLANTA,  GA  30333
Applicant Contact HYE-JOO KIM, PHARM. D.
Correspondent
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON RD., N.E.
MAILSTOP C-18
ATLANTA,  GA  30333
Correspondent Contact HYE-JOO KIM, PHARM. D.
Regulation Number866.3332
Classification Product Code
OQW  
Subsequent Product Codes
NSU   NXD   OEP  
Date Received03/04/2013
Decision Date 05/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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