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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name respiratory virus panel nucleic acid assay system
510(K) Number K113323
Device Name ARTUS INFL A/B RG RT-PCR KIT
Applicant
QIAGEN, GMBH
1201 clopper rd
gaithersburg,  MD  20878
Contact kim davis
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
JJH   OOI  
Date Received11/10/2011
Decision Date 02/06/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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