K252357
- 510(k) number
- K252357
- Device name
- Glucose2
- Applicant
- Abbott Ireland IE
- Product code
- CFR — Hexokinase, Glucose
- Decision date
- 2025-10-24
- Date received
- 2025-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252357.pdf
Official FDA record: K252357
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.