FDA 510(k) Application Details - K213936

Device Classification Name	More FDA Info for this Device
510(K) Number	K213936
Device Name	LIAISON MeMed BV, LIAISON MeMed BV Control Set
Applicant	DiaSorin Inc. 1951 Northwestern Avenue 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	QPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2021
Decision Date	07/14/2022
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