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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Electrophoresis, For Clinical Use
510(k) Number K792553
Device Name AGAROSE BARBITAL-EDTA BUFFER
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 Number862.2485
Classification Product Code
JJN  
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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