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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sudan Black B
510(k) Number K843684
Device Name SIGMA SUDAN BLACK REAGENT 380-1
Applicant
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact LEO BRESSLER
Correspondent
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact LEO BRESSLER
Regulation Number864.1850
Classification Product Code
HZZ  
Date Received09/18/1984
Decision Date 10/31/1984
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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