GLUCOSE (TRINDER) REAGENT— 510(k) K801600

Substantially Equivalent

Gilford Diagnostics

FDA 510(k) clearance K801600 for GLUCOSE (TRINDER) REAGENT, Substantially Equivalent on 1980-08-27. Applicant: Gilford Diagnostics.

Clearance details

Applicant: Gilford Diagnostics
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 1980-07-14
Decision date: 1980-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.