510(k) K022724 ยท NBW System, Test, Blood Glucose, Over The Counter
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Lifescan, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Sep 12, 2002 |
| Received | Aug 16, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022724
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2010 | Lifescan Inc OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by Terminated |
NBW | None listed |
| Mar 17, 2009 | Lifescan Inc OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA Terminated |
NBW | None listed |
| Jan 5, 2007 | Lifescan Inc LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package,
Distributed and Manufactured by: LifeScan, Inc.,
1000 Gibraltar Drive, Milpitas, CA 95037 Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.