FDA 510(k) Application Details - K231214

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster   More FDA Info for this Device
510(K) Number	K231214
Device Name	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Applicant	DiaSorin Inc. 1952 Northwestern Avenue Stillwater, MN 55082 US Other 510(k) Applications for this Company
Contact	Kelly Olien Other 510(k) Applications for this Contact
Regulation Number	866.3900   More FDA Info for this Regulation Number
Classification Product Code	LFY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2023
Decision Date	10/27/2023
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