LDH ISOENZYME COLUMN REAGENT SET

Chromatographic Separation, Lactate Dehydrogenase Isoenzymes

WORTHINGTON BIOCHEMICAL CORP.

The following data is part of a premarket notification filed by Worthington Biochemical Corp. with the FDA for Ldh Isoenzyme Column Reagent Set.

Pre-market Notification Details

Device IDK772356
510k NumberK772356
Device Name:LDH ISOENZYME COLUMN REAGENT SET
ClassificationChromatographic Separation, Lactate Dehydrogenase Isoenzymes
Applicant WORTHINGTON BIOCHEMICAL CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEX  
CFR Regulation Number862.1445 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-12-27
Decision Date1978-01-24

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