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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Fuchsin
510(k) Number K871545
Device Name NEW FUCHSIN SOLUTION
Applicant
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact WILLIAM STARKWEATHER
Correspondent
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact WILLIAM STARKWEATHER
Regulation Number864.1850
Classification Product Code
IDF  
Date Received04/14/1987
Decision Date 04/29/1987
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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