SENOVA(R) BLOOD GLUCOSE MONITOR— 510(k) K032076

Substantially Equivalent

Chdiagnostics, LLC

FDA 510(k) clearance K032076 for SENOVA(R) BLOOD GLUCOSE MONITOR, Substantially Equivalent on 2003-09-30. Applicant: Chdiagnostics, LLC.

Clearance details

Applicant: Chdiagnostics, LLC
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2003-07-07
Decision date: 2003-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, 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.