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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Congo Red
510(k) Number K840798
Device Name AMYLOID STAIN, CONGO RED HT 60
Applicant
Sigma Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sigma Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.1850
Classification Product Code
ICH  
Date Received02/23/1984
Decision Date 03/12/1984
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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