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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 K800568
Device Name TRANSPHOR TM LD LACTATE DEHYDROGENASE
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 Number862.1445
Classification Product Code
CFE  
Date Received03/13/1980
Decision Date 04/04/1980
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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