K220272
- 510(k) number
- K220272
- 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
- 2024-04-26
- Date received
- 2022-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K220272.pdf
Official FDA record: K220272
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.