FDA 510(k) Application Details - K210272

Device Classification Name	Hepatitis A Test (Antibody And Igm Antibody)   More FDA Info for this Device
510(K) Number	K210272
Device Name	Hepatitis A Test (Antibody And Igm Antibody)
Applicant	DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 US Other 510(k) Applications for this Company
Contact	John C. Walker Other 510(k) Applications for this Contact
Regulation Number	866.3310   More FDA Info for this Regulation Number
Classification Product Code	LOL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2021
Decision Date	02/09/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review