ACCU-CHEK AVIVA EXPERT SYSTEM— 510(k) K142089

Substantially Equivalent

Roche Diagnostics Corporation

FDA 510(k) clearance K142089 for ACCU-CHEK AVIVA EXPERT SYSTEM, Substantially Equivalent on 2014-12-17. Applicant: Roche Diagnostics Corporation.

Clearance details

Applicant: Roche Diagnostics Corporation
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2014-08-01
Decision date: 2014-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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.