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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
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