FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K120568
Substantially EquivalentAbbott Diabetes Care, Inc.
FDA 510(k) clearance K120568 for FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2012-03-29. Applicant: Abbott Diabetes Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Diabetes Care, Inc.
- Product code
- Code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alameda, CA, US
Recent devices under product code NBW
view all- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
- K262116 — TRUE METRIX Self Monitoring Blood Glucose System
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K243060 — TeleRPM Gen2 Blood Glucose Monitoring System
- K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel
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 NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
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 K120568
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 K120568.
Data sourced from openFDA. This site is unofficial and independent of the FDA.