ELVI BLOOD UREA NITROGEN

Berthelot Indophenol, Urea Nitrogen

VOLU SOL MEDICAL INDUSTRIES

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

Pre-market Notification Details

Device IDK792417
510k NumberK792417
Device Name:ELVI BLOOD UREA NITROGEN
ClassificationBerthelot Indophenol, Urea Nitrogen
Applicant VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDL  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-26
Decision Date1979-12-07

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