FDA 510(k) Application Details - K200506

Device Classification Name	More FDA Info for this Device
510(K) Number	K200506
Device Name	DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
Applicant	Chembio Diagnostic Systems 3661 Horseblock Road Medford, NY 11763 US Other 510(k) Applications for this Company
Contact	Louise Muscat Sigismondi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2020
Decision Date	06/03/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review