The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Elvi Total Bilirubin & Fractions.
| Device ID | K792415 |
| 510k Number | K792415 |
| Device Name: | ELVI TOTAL BILIRUBIN & FRACTIONS |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-26 |
| Decision Date | 1979-12-07 |