FDA 510(k) Application Details - K161947

Device Classification Name	Enzyme Linked Immunosorbent Assay, T. Cruzi   More FDA Info for this Device
510(K) Number	K161947
Device Name	Enzyme Linked Immunosorbent Assay, T. Cruzi
Applicant	INBIOS INTERNATIONAL, INC. 562 1ST AVE. S. SUITE 600 SEATTLE, WA 98104 US Other 510(k) Applications for this Company
Contact	ESTELA RAYCHAUDHURI Other 510(k) Applications for this Contact
Regulation Number	866.3870   More FDA Info for this Regulation Number
Classification Product Code	MIU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2016
Decision Date	12/16/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review