510(k) K152328 ยท LFR Glucose Dehydrogenase, Glucose
FreeStyle InsuLinx Blood Glucose Monotioring System
| Applicant | Abott Laboratories, Alameda CA, US |
| Decision | Substantially Equivalent, Sep 17, 2015 |
| Received | Aug 18, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152328
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.