510(k) K012975 ยท NBW System, Test, Blood Glucose, Over The Counter
SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
| Applicant | Abbott Laboratories, Bedford MA, US |
| Decision | Substantially Equivalent, Feb 28, 2002 |
| Received | Sep 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012975
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.