Device Classification Name |
joint biological agent identification and diagnostic system (jbaids) tularemia detection kit
|
510(k) Number |
K072547 |
Device Name |
JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 |
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 | 866.3280
|
Classification Product Code |
|
Date Received | 09/10/2007 |
Decision Date | 12/19/2007 |
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
|
|
|