FDA 510(k) Application Details - K160650

Device Classification Name	Hepatitis A Test (Antibody And Igm Antibody)   More FDA Info for this Device
510(K) Number	K160650
Device Name	Hepatitis A Test (Antibody And Igm Antibody)
Applicant	DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082-0285 US Other 510(k) Applications for this Company
Contact	John Walter 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	03/08/2016
Decision Date	08/25/2016
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