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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
510(k) Number K772356
Device Name LDH ISOENZYME COLUMN REAGENT SET
Applicant
Worthington Biochemical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Worthington Biochemical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1445
Classification Product Code
CEX  
Date Received12/27/1977
Decision Date 01/24/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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