Prescription Use Blood Glucose Meter For Near-Patient Testing

PZI · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1345

Classification

FDA Product Code: PZI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1345
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 13
Registered establishments: 8

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown