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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
510(k) Number K792548
Device Name ALKALINE PHOSPHATASE MARKER
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 Number862.1050
Classification Product Code
CIN  
Date Received12/10/1979
Decision Date 01/29/1980
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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