FDA 510(k) Application Details - K191578

Device Classification Name	More FDA Info for this Device
510(K) Number	K191578
Device Name	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
Applicant	Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	Matthew Gee 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	06/14/2019
Decision Date	07/17/2019
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