Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus— 510(k) K173638

Clearance details

Applicant

Bionime Corporation

Product code

Code NBW

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2017-11-24

Decision date

2018-08-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Taichung City, TW

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• K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel2024-11-04

• K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel2024-01-19
• K221062 — RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device2022-09-26
• K190564 — Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB2019-06-02
• K173139 — Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus2018-06-19
• K170143 — GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,2017-07-06

Death

18

Injury

4,740

Malfunction

42,679

Other

6

Total

47,443

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →