510(k) K131419 ยท NBW System, Test, Blood Glucose, Over The Counter
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | I-Sens, Inc., Seoul, Korea, KR |
| Decision | Substantially Equivalent, Aug 9, 2013 |
| Received | May 16, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131419
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.