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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Malachite Green
510(k) Number K864033
Device Name RAPID ACID FAST STAIN
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
KJY  
Date Received10/15/1986
Decision Date 11/13/1986
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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