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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
Applicant Contact kim davis
Correspondent
QIAGEN, GMBH
1201 CLOPPER RD
gaithersburg,  MD  20878
Correspondent 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 (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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