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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 K771322
Device Name ELECTROPHORESIS POWER SUPPLY TESTER
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 Number862.2485
Classification Product Code
JJN  
Date Received07/18/1977
Decision Date 10/18/1977
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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