Device Classification Name |
Assay, Nucleic Acid Amplification, Bacillus Anthracis
|
510(k) Number |
K072631 |
Device Name |
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 |
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 | 866.3045
|
Classification Product Code |
|
Date Received | 09/18/2007 |
Decision Date | 12/20/2007 |
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
|
|
|