CONTOUR NEXT BLOOD GLUCOSE METER— 510(k) K121190

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K121190 for CONTOUR NEXT BLOOD GLUCOSE METER, Substantially Equivalent on 2012-07-26. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2012-04-19
Decision date: 2012-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Tarrytown, NY, US

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Adverse events under product code LFR

product code LFR

Death: 3
Malfunction: 1,634
Total: 1,637

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.