510(k) K141938 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
| Applicant | Terumobct, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Mar 23, 2015 |
| Received | Jul 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141938
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.