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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Haptoglobin, Antigen, Antiserum, Control
510(k) Number K911898
Device Name RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Applicant Contact ALFRED E.PEACOCK,JR.
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Correspondent Contact ALFRED E.PEACOCK,JR.
Regulation Number866.5460
Classification Product Code
DAD  
Date Received04/26/1991
Decision Date 05/08/1991
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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