510(k) K070984 ยท LFR Glucose Dehydrogenase, Glucose
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Nov 1, 2007 |
| Received | Apr 6, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070984
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2020 | Abbott Diabetes Care, Inc. FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 Terminated |
JIN | None listed |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips Terminated |
NBW | None listed |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, Precision Point of Care 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.