510(k) K081975 ยท NBW System, Test, Blood Glucose, Over The Counter
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Nov 26, 2008 |
| Received | Jul 11, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081975
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2020 | Abbott Diabetes Care, Inc. Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 Terminated |
NBW | None listed |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care Optium EZ Blood Glucose Test Strips; Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.