510(k) K012205 ยท NBW System, Test, Blood Glucose, Over The Counter
GLUCOMETER DEX TEST SENSOR
| Applicant | Bayer Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Sep 12, 2001 |
| Received | Jul 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012205
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.