ELVI TOTAL BILIRUBIN & FRACTIONS

Diazo Colorimetry, Bilirubin

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 Bilirubin & Fractions.

Pre-market Notification Details

Device IDK792411
510k NumberK792411
Device Name:ELVI TOTAL BILIRUBIN & FRACTIONS
ClassificationDiazo Colorimetry, Bilirubin
Applicant VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-26
Decision Date1979-12-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.