FreeStyle InsuLinx Blood Glucose Monotioring System— 510(k) K152328
Substantially EquivalentAbott Laboratories
FDA 510(k) clearance K152328 for FreeStyle InsuLinx Blood Glucose Monotioring System, Substantially Equivalent on 2015-09-17. Applicant: Abott Laboratories.
Clearance details
- Applicant
- Abott Laboratories
- Product code
- Code LFR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alameda, CA, 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.