The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Elvi Non-esterified Fatty Acids.
| Device ID | K792555 |
| 510k Number | K792555 |
| Device Name: | ELVI NON-ESTERIFIED FATTY ACIDS |
| Classification | Titrimetric, Fatty Acids |
| Applicant | VOLU SOL MEDICAL INDUSTRIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JLH |
| CFR Regulation Number | 862.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-10 |
| Decision Date | 1980-01-16 |