510(k) K051839 ยท NBW System, Test, Blood Glucose, Over The Counter
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Mar 9, 2006 |
| Received | Jul 7, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051839
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2011 | Abbott Diabetes Care, Inc. FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, man Terminated |
NBW | None listed |
| Aug 3, 2006 | Abbott Diabetes Care, Inc. Abbott brand FreeStyle Flash Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky.
Alameda, CA 94502. Manufactured by:
Flextronics International, Long Jing Industrial Estate Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.