510(k) K120568 ยท NBW System, Test, Blood Glucose, Over The Counter
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Mar 29, 2012 |
| Received | Feb 27, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120568
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2013 | Abbott Diabetes Care, Inc. FreeStyle InsuLinx Blood Glucose Monitoring System:
For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips.
Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda, CA 94502 U Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.