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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
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