FDA 510(k) Application Details - K212181

Device Classification Name	System, Test, Radioallergosorbent (Rast) Immunological   More FDA Info for this Device
510(K) Number	K212181
Device Name	System, Test, Radioallergosorbent (Rast) Immunological
Applicant	Phadia AB Rapsgatan 7P Uppsala 75137 SE Other 510(k) Applications for this Company
Contact	Anna Torell Holm 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	07/13/2021
Decision Date	08/03/2022
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