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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wright'S Stain
510(k) Number K890674
Device Name ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
Applicant
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact TAKES, PHD
Correspondent
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact TAKES, PHD
Regulation Number864.1850
Classification Product Code
IAF  
Date Received02/09/1989
Decision Date 02/24/1989
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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