SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k) clearance K022724 · decided 2002-09-12
Clearance details
- K-number
- K022724
- Device name
- SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
- Applicant
- Lifescan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-16
- Decision date
- 2002-09-12
- Days to decision
- 27 days
- Clearance type
- Special
- 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood G recall (Z-2027-2010) | Lifescan Inc | 2010-07-17 |
| OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureSt recall (Z-1070-2009) | Lifescan Inc | 2009-03-17 |
| LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips recall (Z-0452-2007) | Lifescan Inc | 2007-01-05 |