510(k) K051213 ยท NBW System, Test, Blood Glucose, Over The Counter
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
| Applicant | Abbott Laboratories, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, May 27, 2005 |
| Received | May 12, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips;
MediSense Optium Blood Glucose Electrodes; Terminated |
NBW | None listed |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, Optium Blood Glucose Test Strips; Terminated |
NBW | None listed |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips;
Precision Xtra Blood Glucose & Ketone Monitoring System;
Precision G3b Smartblue 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.