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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cyanomethemoglobin
510(k) Number K896922
Device Name RAICHEM TM HEMOGLOBIN REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Applicant Contact ELSIE SHRAWDER
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Correspondent Contact ELSIE SHRAWDER
Regulation Number864.7500
Classification Product Code
GKK  
Date Received12/11/1989
Decision Date 01/25/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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