PZI

Prescription Use Blood Glucose Meter For Near-Patient Testing

Product code

PZI

Device name

Prescription Use Blood Glucose Meter For Near-Patient Testing

Device class

Class 2

21 CFR

21 CFR 862.1345

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

14 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-06-12.

3 summaries are archived here for direct download.