Device Classification Name |
Gram-Positive Bacteria And Their Resistance Markers
|
510(k) Number |
K152470 |
Device Name |
Great Basin Staph ID/R Blood Culture Panel |
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 | 866.3365
|
Classification Product Code |
|
Date Received | 08/31/2015 |
Decision Date | 03/25/2016 |
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
|
Recalls |
CDRH Recalls
|
|
|