510(k) K033845 ยท NBW System, Test, Blood Glucose, Over The Counter
PRECISION XCEED DIABETES MONITORING SYSTEM
| Applicant | Abbott Laboratories, Bedford MA, US |
| Decision | Substantially Equivalent, Jan 8, 2004 |
| Received | Dec 11, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2008 | Abbott Diabetes Care, Inc. Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xceed meter, Optium Xceed meter, Optium meter, ReliOn Ultima meter, Rite Aid meter, Terminated |
NBW | None listed |
| Jun 7, 2007 | Abbott Diabetes Care, Inc. Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit. Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.