ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS— 510(k) K024194
Substantially EquivalentLifescan, Inc.
FDA 510(k) clearance K024194 for ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS, Substantially Equivalent on 2003-02-07. Applicant: Lifescan, Inc.. Device class: 2.
Clearance details
- Applicant
- Lifescan, Inc.
- Product code
- Product 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
- Milpitas, CA, US
Recent devices under product code NBW
view all- K260738 — Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System
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- K260687 — VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more
- K260689 — CVS Advanced PLUS Blood Glucose Monitoring System
- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
More clearances from Lifescan, Inc.
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.