GLUCOSE (GDH) REAGENT— 510(k) K791213

Substantially Equivalent

Gilford Diagnostics

FDA 510(k) clearance K791213 for GLUCOSE (GDH) REAGENT, Substantially Equivalent on 1979-08-10. Applicant: Gilford Diagnostics.

Clearance details

Applicant: Gilford Diagnostics
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 1979-07-02
Decision date: 1979-08-10
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.