FDA 510(k) Application Details - K192046

Device Classification Name	More FDA Info for this Device
510(K) Number	K192046
Device Name	LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
Applicant	DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082-0285 US Other 510(k) Applications for this Company
Contact	John C. Walter 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	07/31/2019
Decision Date	10/28/2019
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