FDA 510(k) Application Details - K182479

Device Classification Name	System, Test, Radioallergosorbent (Rast) Immunological   More FDA Info for this Device
510(K) Number	K182479
Device Name	System, Test, Radioallergosorbent (Rast) Immunological
Applicant	Hycor Biomedical 7272 Chapman Avenue Garden Grove, CA 92841 US Other 510(k) Applications for this Company
Contact	Tara Viviani 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	09/10/2018
Decision Date	12/04/2018
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