FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001— 510(k) K000582
Substantially EquivalentAbbott Diabetes Care, Inc.
FDA 510(k) clearance K000582 for FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001, Substantially Equivalent on 2000-12-05. Applicant: Abbott Diabetes Care, Inc..
Clearance details
- Applicant
- Abbott Diabetes Care, Inc.
- Product code
- Code LFR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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.