Device Classification Name |
Bordetella Pertussis Dna Assay System
|
510(k) Number |
K170284 |
Device Name |
Great Basin Bordetella Direct Test |
Applicant |
GREAT BASIN SCIENTIFIC, INC. |
2441 S. 3850 WEST |
SUITE 100 |
SALT LAKE CITY,
UT
84120
|
|
Applicant Contact |
SUZETTE CHANCE |
Correspondent |
GREAT BASIN SCIENTIFIC, INC. |
2441 S. 3850 WEST |
SUITE 100 |
SALT LAKE CITY,
UT
84120
|
|
Correspondent Contact |
SUZETTE CHANCE |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/30/2017 |
Decision Date | 03/31/2017 |
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
|
|
|