ADENOVIRUS R-GENE US


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

Correspodent Contact eric brisson
Regulation Number 866.3980
Classification Product Code
OCC  
Date Received 07/02/2012
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