510(k) K023194 ยท CGA Glucose Oxidase, Glucose
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
| Applicant | Lifescan, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Oct 24, 2002 |
| Received | Sep 25, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023194
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2010 | Lifescan Inc OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico
Terminated |
NBW | None listed |
| Jan 5, 2007 | Lifescan Inc LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package,
Distributed and Manufactured by: LifeScan, Inc.,
1000 Gibraltar Drive, Milpitas, CA 95037 Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.