Device Classification Name	System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number	K982343
Device Name	ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3
Applicant	Pharmacia & Upjohn Co. 5094 St. Andrews Dr. Westervillle,  OH  43082
Applicant Contact	KAREN E MATIS
Correspondent	Pharmacia & Upjohn Co. 5094 St. Andrews Dr. Westervillle,  OH  43082
Correspondent Contact	KAREN E MATIS
Regulation Number	866.5750
Classification Product Code	DHB
Date Received	07/06/1998
Decision Date	09/15/1998
Decision	Substantially Equivalent (SESE)
Regulation Medical Specialty	Immunology
510k Review Panel	Immunology
Summary	Summary
Type	Traditional
Reviewed by Third Party	No
Combination Product	No
Predetermined Change Control Plan Authorized	No