THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS— 510(k) K070984
Substantially EquivalentAbbott Diabetes Care, Inc.
FDA 510(k) clearance K070984 for THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS, Substantially Equivalent on 2007-11-01. 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
- K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM
- 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 →
Recalls naming K070984
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070984.
Data sourced from openFDA. This site is unofficial and independent of the FDA.