ACCU-CHEK ADVANTAGE METER— 510(k) K000365

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K000365 for ACCU-CHEK ADVANTAGE METER, Substantially Equivalent on 2000-02-23. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2000-02-04
Decision date: 2000-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, 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.