FDA 510(k) Application Details - K182793

Device Classification Name	System, Test, Radioallergosorbent (Rast) Immunological   More FDA Info for this Device
510(K) Number	K182793
Device Name	System, Test, Radioallergosorbent (Rast) Immunological
Applicant	Hitachi Chemical Diagnostics, Inc. 630 Clyde Court Mountain View, CA 94043 US Other 510(k) Applications for this Company
Contact	Donald Postel Other 510(k) Applications for this Contact
Regulation Number	866.5750   More FDA Info for this Regulation Number
Classification Product Code	DHB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2018
Decision Date	03/19/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review