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510(k) K221349

Device
XPER Technology PREMIUM Pro Blood Glucose Monitoring System
Applicant
Taidoc Technology Corporation
510(k) number
K221349
Product code
PZI
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-19
Date received
2022-05-09
Regulation
862.1345
Classification name
Prescription Use Blood Glucose Meter For Near-Patient Testing
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Dual Track
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jacky Chou
Address
B1-7f, #127, Wugong 2nd Rd. New Taipei City TW 24888 24888

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZI#

510(k), Device, Applicant table
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K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation2018-12-13
K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation2018-07-12
K163490StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation2017-01-06
K161856StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation2016-11-15
K152986StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation2016-01-27
K150461StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation2015-05-20
K150281StatStrip Glucose Hospital MeterNova Biomedical Corporation2015-05-06
K132121STATSTRIP GLUCOSE HOSPITAL METER SYSTEMNova Biomedical Corporation2014-09-24