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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methylene Blue, Tissue Stain
510(k) Number K875310
Device Name RETICULOCYTE STAIN
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
KFC  
Date Received12/29/1987
Decision Date 02/09/1988
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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