XPER Technology PREMIUM Pro Blood Glucose Monitoring System
FDA 510(k) clearance K221349 · decided 2024-11-19
Clearance details
- K-number
- K221349
- Device name
- XPER Technology PREMIUM Pro Blood Glucose Monitoring System
- Applicant
- Taidoc Technology Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-05-09
- Decision date
- 2024-11-19
- Days to decision
- 925 days
- Clearance type
- Dual Track
- Product code
- PZI
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- New Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.