CFR
- Product code
- CFR
- Device name
- Hexokinase, Glucose
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1345
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 145
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253490 | 2026-02-12 | Roche Diagnostics | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro | |
| K252357 | 2025-10-24 | Abbott Ireland | Glucose2 |
Official FDA classification page: CFR
Classification and pathway per current FDA publications. Data from openFDA (CC0).