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510(k) K221349

XPER Technology PREMIUM Pro Blood Glucose Monitoring System by Taidoc Technology Corporation — Product Code PZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2024
Date Received
May 9, 2022
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.

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