510(k) K070850 ยท NBW System, Test, Blood Glucose, Over The Counter
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Apr 10, 2007 |
| Received | Mar 28, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070850
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2009 | Abbott Diabetes Care, Inc. FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, man Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.