510(k) K252323
K252323 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "cobas pulse blood glucose monitoring system". The FDA issued a decision of Substantially Equivalent on June 12, 2026. The device falls under product code PZI (Prescription Use Blood Glucose Meter For Near-Patient Testing), a Class II device regulated under 21 CFR 862.1345. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2026
- Date Received
- July 25, 2025
- Clearance Type
- Dual Track
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prescription Use Blood Glucose Meter For Near-Patient Testing
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type
Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.