FDA 510(k) Application Details - K161964

Device Classification Name	Hepatitis A Test (Antibody And Igm Antibody)   More FDA Info for this Device
510(K) Number	K161964
Device Name	Hepatitis A Test (Antibody And Igm Antibody)
Applicant	Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	Philip Liu 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	07/18/2016
Decision Date	10/13/2016
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