510(k) K092602 ยท NBW System, Test, Blood Glucose, Over The Counter
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, May 14, 2010 |
| Received | Aug 25, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092602
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2013 | Abbott Diabetes Care, Inc. FreeStyle Blood Glucose Test Strips;
For in vitro diagnostic testing.
50 count
UPC 6 99073 12050 2;
Freestyle Blood Glucose Test Strips; for Institutional Use only
50 count:
UPC 6 99073 70792 5
Manu Terminated |
NBW | None listed |
| Dec 17, 2013 | Abbott Diabetes Care, Inc. FreeStyle Lite Blood Glucose Test Strips;
For in vitro diagnostic testing.
50 count; 100 count Product of Ireland;
UPC 6 99073 70819 9; - 50 count
UPC 6 99073 70822 9 - 50 count
UPC 6 99073 71026 0 Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.