ACCU-CHEK AVIVA PLUS SYSTEM— 510(k) K133862

Substantially Equivalent

Roche Diagnostics Corporation

FDA 510(k) clearance K133862 for ACCU-CHEK AVIVA PLUS SYSTEM, Substantially Equivalent on 2014-04-29. Applicant: Roche Diagnostics Corporation.

Clearance details

Applicant: Roche Diagnostics Corporation
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2013-12-19
Decision date: 2014-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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.