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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sudan Black B
510(k) Number K792552
Device Name AMIDO BLACK 10B STAIN
Applicant
Electrophoresis Corp. of America
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Electrophoresis Corp. of America
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.1850
Classification Product Code
HZZ  
Date Received12/10/1979
Decision Date 12/18/1979
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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