ASCENSIA ELITE DIABETES CARE SYSTEM— 510(k) K043311

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K043311 for ASCENSIA ELITE DIABETES CARE SYSTEM, Substantially Equivalent on 2004-12-22. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2004-12-01
Decision date: 2004-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Elkhart, IN, US

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Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

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.