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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K831263
Device Name ELECTROPHORESIS CONTROLS-3 IN 1
Applicant
Corning Medical & Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Corning Medical & Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/18/1983
Decision Date 07/07/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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