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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrophoretic, protein fractionation
510(k) Number K781116
Device Name ECA BUFFER, PH 816
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 Number862.1630
Classification Product Code
CEF  
Date Received07/03/1978
Decision Date 08/10/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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