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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
510(k) Number K904175
Device Name RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111 -1203
Applicant Contact NORBERT NEUMANN
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111 -1203
Correspondent Contact NORBERT NEUMANN
Regulation Number866.5420
Classification Product Code
LKL  
Date Received09/11/1990
Decision Date 11/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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