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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 K121942
Model 69-010B-US
Device Name ADENOVIRUS R-GENE US
Original Applicant
ARGENE SA
parc technologique delta sud
varilhes,  FR 09120
Original Contact eric brisson
Regulation Number866.3980
Classification Product Code
OCC  
Date Received07/11/2012
Decision Date 02/08/2013
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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