510(k) K021781— EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS

Substantially Equivalent

Chay Medical, LLC

Clearance details

Applicant: Chay Medical, LLC
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2002-05-30
Decision date: 2002-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calistoga, CA, US

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.