510(k) K200898 ยท CIX Bromcresol Green Dye-Binding, Albumin
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
| Applicant | Medicon Hellas S.A, Gerakas, GR |
| Decision | Substantially Equivalent, Sep 21, 2021 |
| Received | Apr 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200898
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.