510(k) K193115 ยท OEG Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
EUROIMMUN Anti-BP230-CF ELISA (IgG)
| Applicant | Euroimmun Us, Inc., Mountain Lakes NJ, US |
| Decision | Substantially Equivalent, Sep 17, 2020 |
| Received | Nov 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193115
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.