510(k) K182593 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
KET-1 Blood Ketone Monitoring System
| Applicant | Apex BioTechnology Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Dec 18, 2018 |
| Received | Sep 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182593
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.