510(k) K181273 ยท NBW System, Test, Blood Glucose, Over The Counter
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Nov 1, 2018 |
| Received | May 14, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181273
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.