Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K132159 |
Device Name |
PROADENO+ ASSAY |
Applicant |
GEN-PROBE PRODESSE, INC |
20925 CROSSROADS CIRCLE |
WAUKESHA,
WI
53186
|
|
Applicant Contact |
EMILY ZIEGLER |
Correspondent |
GEN-PROBE PRODESSE, INC |
20925 CROSSROADS CIRCLE |
WAUKESHA,
WI
53186
|
|
Correspondent Contact |
EMILY ZIEGLER |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/12/2013 |
Decision Date | 08/14/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|