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.. Device class: 2.
Clearance details
- Applicant
- Abbott Diabetes Care, Inc.
- Product code
- Code LFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code LFR
view all- K152328 — FreeStyle InsuLinx Blood Glucose Monotioring System
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- K133537 — EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
- K131727 — CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
- K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
More clearances from Abbott Diabetes Care, Inc.
view all- K233537 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K223435 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K222447 — FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
- K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System
- K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring System
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.