The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Elvi Uric Acid.
Device ID | K792412 |
510k Number | K792412 |
Device Name: | ELVI URIC ACID |
Classification | Acid, Uric, Phosphotungstate Reduction |
Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDH |
CFR Regulation Number | 862.1775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-26 |
Decision Date | 1979-12-07 |