ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K131366
Substantially EquivalentRoche Diagnostics Operations, Inc.
FDA 510(k) clearance K131366 for ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2013-10-11. Applicant: Roche Diagnostics Operations, Inc..
Clearance details
- Applicant
- Roche Diagnostics Operations, Inc.
- Product code
- Code LFR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Adverse events under product code LFR
product code LFR- Death
- 3
- Malfunction
- 1,634
- Total
- 1,637
Source: openFDA MAUDE database, through . 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.