Elvi Creatinine
by Volu Sol Medical Industries 510(k)
Active
510(k) K792404
Overview
The Elvi Creatinine is an alkaline picrate, colorimetry, creatinine device used for clinical chemistry applications. It is designed to facilitate the measurement of creatinine levels in a laboratory setting.
This device is regulated as a Class II medical device under regulation number 862.1225. It has received FDA 510(k) clearance, identified by reference number K792404.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792404 | Date7 Dec 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CGX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1225
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent