Device Classification Name |
Assay, Direct, Nucleic Acid Amplification, Q Fever
|
510(k) Number |
K103207 |
Device Name |
JBAIDS Q FEVER DETECTION KIT |
Applicant |
IDAHO TECHNOLOGY, INC. |
390 Wakara Way |
Salt Lake City,
UT
84108
|
|
Applicant Contact |
BETH LINGENFELTER |
Correspondent |
IDAHO TECHNOLOGY, INC. |
390 Wakara Way |
Salt Lake City,
UT
84108
|
|
Correspondent Contact |
BETH LINGENFELTER |
Regulation Number | 866.3500
|
Classification Product Code |
|
Date Received | 11/01/2010 |
Decision Date | 05/20/2011 |
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
|
|
|