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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Immunoassay, Igg
510(k) Number K894416
Device Name RAICHEM(TM) SPIA(TM) IGG REAGENTS
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Applicant Contact J SHRAWDER,PHD
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Correspondent Contact J SHRAWDER,PHD
Regulation Number866.5530
Classification Product Code
KTO  
Date Received07/17/1989
Decision Date 08/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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