GlucoLeader Enhance Blood Glucose Monitoring System— 510(k) K182428

Clearance details

Applicant

Hmd Biomedical, Inc.

Product code

Code NBW

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2018-09-06

Decision date

2019-05-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hsin Chu County, TW

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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 →