CGX
- Product code
- CGX
- Device name
- Alkaline Picrate, Colorimetry, Creatinine
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1225
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 159
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252206 | 2026-01-09 | Nova Biomedical Corporation | Nova Allegro UACR Assay, Nova Allegro Analyzer | |
| K251058 | 2025-11-26 | Truvian Health | Tru Kidney Health Test Panel; Tru Analyzer | |
| K242685 | 2024-12-04 | Siemens Healthcare Diagnostics, Inc. | Atellica® CH Creatinine_3 (Crea3) | |
| K221813 | 2024-11-19 | Nova Biomedical Corporation | Nova Allegro UACR Assay, Nova Allegro Analyzer |
Official FDA classification page: CGX
Classification and pathway per current FDA publications. Data from openFDA (CC0).