FDA 510(k) Application Details - K190428

Device Classification Name	Hepatitis A Test (Antibody And Igm Antibody)   More FDA Info for this Device
510(K) Number	K190428
Device Name	Hepatitis A Test (Antibody And Igm Antibody)
Applicant	Roche Diagnostics 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Jamie Ferguson 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	02/22/2019
Decision Date	08/13/2019
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