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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 K791827
Device Name LDH CLINI GEL KIT
Applicant
Clinical Sciences, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Clinical Sciences, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1445
Classification Product Code
CFE  
Date Received09/17/1979
Decision Date 10/01/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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