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

Name: FDA 510(k) clearance K021781
Creator: U.S. Food and Drug Administration
Published: 2002-08-30

Substantially Equivalent

Chay Medical, LLC

FDA 510(k) clearance K021781 for EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS, Substantially Equivalent on 2002-08-30. Applicant: Chay Medical, LLC. Device class: 2.

Clearance details

Applicant: Chay Medical, LLC
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2002-05-30
Decision date: 2002-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calistoga, CA, US

Download summary PDF View on FDA.gov ↗

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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.