Device Classification Name |
Leishmania Spp. Antigen Detection Assay
|
510(k) Number |
K141341 |
Device Name |
CL DETECT RAPID TEST |
Applicant |
INBIOS INTERNATIONAL INC. |
562 1ST AVE S STE 600 |
SEATTLE,
WA
98104
|
|
Applicant Contact |
ESTELA RAYCHAUDHURI |
Correspondent |
INBIOS INTERNATIONAL INC. |
562 1ST AVE S STE 600 |
SEATTLE,
WA
98104
|
|
Correspondent Contact |
ESTELA RAYCHAUDHURI |
Regulation Number | 866.3870
|
Classification Product Code |
|
Date Received | 05/21/2014 |
Decision Date | 11/14/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01769612 NCT01865032
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|