ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE— 510(k) K043529

Name: FDA 510(k) clearance K043529
Creator: U.S. Food and Drug Administration
Published: 2005-04-08

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K043529 for ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE, Substantially Equivalent on 2005-04-08. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code NDC
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2004-12-21
Decision date: 2005-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

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.