K252323
- 510(k) number
- K252323
- Device name
- cobas pulse blood glucose monitoring system
- Applicant
- Roche Diagnostics IN · US
- Product code
- PZI — Prescription Use Blood Glucose Meter For Near-Patien
- Decision date
- 2026-06-12
- Date received
- 2025-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252323.pdf
Official FDA record: K252323
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.