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PZI — Prescription Use Blood Glucose Meter For Near-Patient Testing Class II

FDA Device Classification

Classification Details

Product Code
PZI
Device Class
Class II
Regulation Number
862.1345
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K221349taidoc technology corporationXPER Technology PREMIUM Pro Blood Glucose Monitoring SystemNovember 19, 2024
K220272roche diagnosticscobas pulse blood glucose monitoring systemApril 26, 2024
K232075nova biomedical corporationStatStrip Glucose Hospital Meter SystemFebruary 23, 2024
K200788arkrayAssure Titanium Blood Glucose Monitoring SystemMay 23, 2022
K182552nova biomedical corporationStatStrip Xpress Glucose Hospital Meter SystemDecember 13, 2018
K182549nova biomedical corporationStatStrip Xpress 2 Glucose Hospital Meter SystemDecember 13, 2018
K181043nova biomedical corporationStatStrip Glucose Hospital Meter SystemJuly 12, 2018
K163490nova biomedical corporationStatStrip Xpress 2 Glucose Hospital Meter SystemJanuary 6, 2017
K161856nova biomedical corporationStatStrip Xpress Glucose Hospital Meter SystemNovember 15, 2016
K152986nova biomedical corporationStatStrip Xpress 2 Glucose Hospital Meter SystemJanuary 27, 2016
K150461nova biomedical corporationStatStrip Xpress Glucose Hospital Meter SystemMay 20, 2015
K150281nova biomedical corporationStatStrip Glucose Hospital MeterMay 6, 2015
K132121nova biomedical corporationSTATSTRIP GLUCOSE HOSPITAL METER SYSTEMSeptember 24, 2014