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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number866.3870
Classification Product Code
PIT  
Date Received05/21/2014
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
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