TRANSPHOR TM LD LACTATE DEHYDROGENASE

Electrophoretic, Lactate Dehydrogenase Isoenzymes

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Transphor Tm Ld Lactate Dehydrogenase.

Pre-market Notification Details

Device IDK800568
510k NumberK800568
Device Name:TRANSPHOR TM LD LACTATE DEHYDROGENASE
ClassificationElectrophoretic, Lactate Dehydrogenase Isoenzymes
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCFE  
CFR Regulation Number862.1445 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-13
Decision Date1980-04-04

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