MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K062195
Substantially EquivalentLifescan, Inc.
FDA 510(k) clearance K062195 for MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2006-08-16. 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
- Special
- 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
- K261293 — EASYMAX Voice Blood Glucose Monitoring System
- 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 →
Recalls naming K062195
K-number listed on FDA's recall record- Z-1936-2021 — ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
- Z-1938-2021 — ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
- Z-1129-2013 — LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062195.
Data sourced from openFDA. This site is unofficial and independent of the FDA.