ULTRACHEM GLUC-DH— 510(k) K813427

Substantially Equivalent

Harleco

FDA 510(k) clearance K813427 for ULTRACHEM GLUC-DH, Substantially Equivalent on 1981-12-31. Applicant: Harleco.

Clearance details

Applicant: Harleco
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 1981-12-07
Decision date: 1981-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.