Dario Blood Glucose Monitoring System— 510(k) K150817
Substantially EquivalentLabstyle Innovations, Ltd.
FDA 510(k) clearance K150817 for Dario Blood Glucose Monitoring System, Substantially Equivalent on 2015-12-21. Applicant: Labstyle Innovations, Ltd.. Device class: 2.
Clearance details
- Applicant
- Labstyle Innovations, Ltd.
- 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
- Traditional
- Location
- Charlott, NC, 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 Labstyle Innovations, Ltd.
view allAdverse 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 K150817
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 K150817.
Data sourced from openFDA. This site is unofficial and independent of the FDA.