510(k) K200475 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
IDS-iSYS Ostase BAP
| Applicant | Immunodiagnostic Systems , Ltd., Boldon, GB |
| Decision | Substantially Equivalent, Sep 30, 2020 |
| Received | Feb 26, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200475
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.