510(k) K183375 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
| Applicant | Horiba, Ltd., Kyoto, JP |
| Decision | Substantially Equivalent, Feb 12, 2019 |
| Received | Dec 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183375
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.