FDA 510(k) Application Details - K192524

Device Classification Name	System, Test, Immunological, Antigen, Tumor   More FDA Info for this Device
510(K) Number	K192524
Device Name	System, Test, Immunological, Antigen, Tumor
Applicant	Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Kristin Maddaloni Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	MOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2019
Decision Date	09/04/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review