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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Eosin Y
510(k) Number K880596
Device Name EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE
Applicant
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact TAKES, PHD
Correspondent
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact TAKES, PHD
Regulation Number864.1850
Classification Product Code
HYB  
Date Received02/11/1988
Decision Date 03/31/1988
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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