Device Classification Name |
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
|
510(k) Number |
K123274 |
Device Name |
PROGASTRO SSCS ASSAY |
Applicant |
GEN-PROBE PRODESSE, INC. |
20925 CROSSROADS CIRCLE |
WAUKESHA,
WI
53186
|
|
Applicant Contact |
KAREN HARRINGTON |
Correspondent |
GEN-PROBE PRODESSE, INC. |
20925 CROSSROADS CIRCLE |
WAUKESHA,
WI
53186
|
|
Correspondent Contact |
KAREN HARRINGTON |
Regulation Number | 866.3990
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/19/2012 |
Decision Date | 01/16/2013 |
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
|
|
|