FDA 510(k) Applications for Medical Device Product Code: QFO ()

FDA 510(k) Applications for Medical Device Product Code "QFO"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K200506	Chembio Diagnostic Systems	DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader	06/03/2020
K192046	DiaSorin Inc.	LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set	10/28/2019
DEN180069	InBios International, Inc.	ZIKV Detect 2.0 IgM Capture ELISA	05/23/2019
K191578	Siemens Healthcare Diagnostics Inc.	ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control	07/17/2019