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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrophoretic, lactate dehydrogenase isoenzymes
510(k) Number K791656
Device Name ENZYME STABILIZING REAGENT (ESR)
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 Number862.1445
Classification Product Code
CFE  
Date Received08/21/1979
Decision Date 09/17/1979
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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