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 Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/10/2011 |
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
|
|
|