FDA 510(k) Application Details - K000132

Device Classification Name	System, Test, Radioallergosorbent (Rast) Immunological   More FDA Info for this Device
510(K) Number	K000132
Device Name	System, Test, Radioallergosorbent (Rast) Immunological
Applicant	PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. WESTERVILLLE, OH 43082 US Other 510(k) Applications for this Company
Contact	KAREN E MATIS 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	01/18/2000
Decision Date	02/18/2000
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