510(k) K040814 ยท NBW System, Test, Blood Glucose, Over The Counter
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
| Applicant | Abbott Laboratories, Bedford MA, US |
| Decision | Substantially Equivalent, Apr 15, 2004 |
| Received | Mar 30, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040814
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2020 | Abbott Diabetes Care, Inc. Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144 Terminated |
NBW | None listed |
| 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.