Clearance Summary
ELVI NON-ESTERIFIED FATTY ACIDS received FDA 510(k) clearance under submission number K792555, sponsored by Volu Sol Medical Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1980-01-16.
- Submission: K792555
- Applicant / Sponsor: Volu Sol Medical Industries
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1290
- Decision date: 1980-01-16
Classification & Regulation
This clearance is catalogued under FDA product code JLH and 21 CFR 862.1290, within the Clinical Chemistry review panel as a Class I device.