GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM— 510(k) K032985

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

2003-09-24

Decision date

2003-10-21

Decision

Substantially Equivalent

Clearance type

Special

Location

Ocean, NJ, US

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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 →