510(k) K153601 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Spectra Optia Apheresis System
| Applicant | Terumobct, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Jan 14, 2016 |
| Received | Dec 16, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153601
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.