Device Classification Name |
c. difficile toxin gene amplification assay
|
510(k) Number |
K133936 |
Device Name |
ARTUS C. DIFFICILE QS-RGQ MDX KIT |
Applicant |
QIAGEN, GMBH |
1201 CLOPPER RD |
GAITHERSBURG,
MD
20878
|
|
Applicant Contact |
Kimberly Mapp |
Correspondent |
QIAGEN, GMBH |
1201 CLOPPER RD |
GAITHERSBURG,
MD
20878
|
|
Correspondent Contact |
Kimberly Mapp |
Regulation Number | 866.3130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/23/2013 |
Decision Date | 04/04/2014 |
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
|
|
|