The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Elvi Blood Urea Nitrogen.
Device ID | K792417 |
510k Number | K792417 |
Device Name: | ELVI BLOOD UREA NITROGEN |
Classification | Berthelot Indophenol, Urea Nitrogen |
Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDL |
CFR Regulation Number | 862.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-26 |
Decision Date | 1979-12-07 |