ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K101299

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K101299 for ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2011-09-21. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2010-05-10
Decision date: 2011-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.