Device Classification Name |
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
|
510(k) Number |
K132237 |
Device Name |
PRODESSE PROFAST+ 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 | 866.3332
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/18/2013 |
Decision Date | 08/26/2013 |
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
|
|
|