510(k) K132429 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
| Applicant | Terumobct, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Dec 6, 2013 |
| Received | Aug 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132429
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.