510(k) K170463 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Apr 13, 2018 |
| Received | Feb 15, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170463
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.