ACCU-CHEK COMPACT TEST STRIP— 510(k) K031755

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K031755 for ACCU-CHEK COMPACT TEST STRIP, Substantially Equivalent on 2003-07-03. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2003-06-06
Decision date: 2003-07-03
Decision: Substantially Equivalent
Clearance type: Special
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.