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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 K832314
Device Name CARDIZYME PLUS LD #65094/93
Applicant
EM INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EM INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1445
Classification Product Code
CFE  
Date Received07/14/1983
Decision Date 09/01/1983
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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