FDA 510(k) Application Details - K190219

Device Classification Name	More FDA Info for this Device
510(K) Number	K190219
Device Name	Simplexa VZV Direct, Simplexa VZV Positive Control Pack
Applicant	DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 US Other 510(k) Applications for this Company
Contact	Sharon Young Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2019
Decision Date	05/13/2019
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