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