ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k) clearance K024194 · decided 2003-02-07
Clearance details
- K-number
- K024194
- Device name
- ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
- Applicant
- Lifescan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-20
- Decision date
- 2003-02-07
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Milpitas, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lifescan
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distri recall (Z-1596-05) | Lifescan Inc | 2005-09-29 |
| LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number recall (Z-0887-05) | Lifescan Inc | 2005-06-14 |
| LifeScan brand OneTouch Ultra Blood Glucose Meter recall (Z-0821-05) | Lifescan Inc | 2005-05-17 |
| LifeScan brand OneTouch FastTake Blood Glucose Meter recall (Z-0822-05) | Lifescan Inc | 2005-05-17 |
| LifeScan Brand InDuo Blood Glucose Meter recall (Z-0823-05) | Lifescan Inc | 2005-05-17 |