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 Number | 866.3980
|
Classification Product Code |
|
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
|
|
|