K961311

Substantially Equivalent

HEMOCUE B-GLUCOSE SYSTEM

Applicant: Hemocue, Inc.
Product code: LFR
Advisory panel: Clinical Chemistry
Date received: 1996-04-04
Decision date: 1996-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

Adverse events under product code LFR

product code LFR

Death: 3
Malfunction: 1,634
Total: 1,637

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.