FDA 510(k) Application Details - K190315

Device Classification Name	System, Test, Radioallergosorbent (Rast) Immunological   More FDA Info for this Device
510(K) Number	K190315
Device Name	System, Test, Radioallergosorbent (Rast) Immunological
Applicant	Phadia AB Rapsgatan 7P Uppsala 75137 SE Other 510(k) Applications for this Company
Contact	Ulf Karlberg 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	02/13/2019
Decision Date	05/14/2019
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