ELVI TOTAL PROTEINS

2,4-dinitrophenylhydrazine, Lactate Dehydrogenase

VOLU SOL MEDICAL INDUSTRIES

The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Elvi Total Proteins.

Pre-market Notification Details

Device IDK792416
510k NumberK792416
Device Name:ELVI TOTAL PROTEINS
Classification2,4-dinitrophenylhydrazine, Lactate Dehydrogenase
Applicant VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCER  
CFR Regulation Number862.1440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-26
Decision Date1979-12-07

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