510(k) K970556 ยท CGA Glucose Oxidase, Glucose
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Lifescan, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, May 12, 1997 |
| Received | Feb 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2003 | Lifescan Inc OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use) Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.