510(k) K151368 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
| Applicant | Terumo Bct, Lakewood CO, US |
| Decision | Substantially Equivalent, Sep 11, 2015 |
| Received | May 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151368
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.