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510(k) K141341

CL DETECT RAPID TEST by InBios International, Inc. — Product Code PIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2014
Date Received
May 21, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Leishmania Spp. Antigen Detection Assay
Device Class
Class I
Regulation Number
866.3870
Review Panel
MI
Submission Type

An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.

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