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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
510(k) Number K080570
Device Name CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
Applicant
Centers For Disease Control and Prevention
1600 Clifton Rd. Ms-C12
Atlanta,  GA  30333
Applicant Contact STEPHEN LINDSTROM
Correspondent
Centers For Disease Control and Prevention
1600 Clifton Rd. Ms-C12
Atlanta,  GA  30333
Correspondent Contact STEPHEN LINDSTROM
Regulation Number866.3332
Classification Product Code
NXD  
Date Received02/29/2008
Decision Date 09/30/2008
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
Predetermined Change
Control Plan Authorized		 No
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