510(k) K092638 ยท NBW System, Test, Blood Glucose, Over The Counter
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Jun 15, 2010 |
| Received | Aug 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092638
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2014 | Abbott Diabetes Care, Inc. FreeStyle Blood Glucose Monitors System.
For in vitro diagnostic use only. Store at room
temperature below 86 degrees F (30 degrees C). Use test strips
only within the system operating temperature
ran Terminated |
NBW | None listed |
| Mar 18, 2014 | Abbott Diabetes Care, Inc. FreeStyle Flash Blood Glucose Monitors System.
Meter made in China;
Distributed by TheraSense, Alameda, CA
The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle C Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.