Chagas Detect Plus Rapid Test

Enzyme Linked Immunosorbent Assay, T. Cruzi

INBIOS INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Inbios International, Inc. with the FDA for Chagas Detect Plus Rapid Test.

Pre-market Notification Details

Device IDK161947
510k NumberK161947
Device Name:Chagas Detect Plus Rapid Test
ClassificationEnzyme Linked Immunosorbent Assay, T. Cruzi
Applicant INBIOS INTERNATIONAL, INC. 562 1ST AVE. S. SUITE 600 Seattle,  WA  98104
ContactEstela Raychaudhuri
CorrespondentEstela Raychaudhuri
INBIOS INTERNATIONAL, INC. 562 1ST AVE. S. SUITE 600 Seattle,  WA  98104
Product CodeMIU  
CFR Regulation Number866.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-14
Decision Date2016-12-16

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