510(k) K183306 · NBW System, Test, Blood Glucose, Over The Counter
GLUCOCARD® W onyx Blood Glucose Monitoring System
| Applicant | Arkray Factory, Inc., Kamigyo-Ku, JP |
| Decision | Substantially Equivalent, Apr 10, 2019 |
| Received | Nov 28, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183306
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.