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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Purpose Reagent
510(k) Number K811800
Device Name BLUING REAGENT
Applicant
Richard-Allan Medical Ind., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Richard-Allan Medical Ind., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.4010
Classification Product Code
PPM  
Date Received06/24/1981
Decision Date 08/12/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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