Device Classification Name |
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
|
510(k) Number |
K152955 |
Device Name |
Great Basin Shiga Toxin Direct Test |
Applicant |
GREAT BASIN SCIENTIFIC, INC. |
2441 S. 3850 West |
Salt Lake City,
UT
84120
|
|
Applicant Contact |
Chuck Owen |
Correspondent |
GREAT BASIN SCIENTIFIC, INC. |
2441 S. 3850 West |
Salt Lake City,
UT
84120
|
|
Correspondent Contact |
Chuck Owen |
Regulation Number | 866.3990
|
Classification Product Code |
|
Date Received | 10/07/2015 |
Decision Date | 03/22/2016 |
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
|
|
|