FDA 510(k) Application Details - K212147

Device Classification Name	More FDA Info for this Device
510(K) Number	K212147
Device Name	Simplexa COVID-19 Direct
Applicant	DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 US Other 510(k) Applications for this Company
Contact	Tara Viviani Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2021
Decision Date	09/13/2022
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