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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
Applicant Contact NORBERT NEUMANN
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
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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