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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Dye Powder
510(k) Number K871476
Device Name SILVER STAIN REAGENT SYSTEM
Applicant
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact WILLIAM STARKWEATHER
Correspondent
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact WILLIAM STARKWEATHER
Regulation Number864.1850
Classification Product Code
LEF  
Date Received04/14/1987
Decision Date 05/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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