K151368 is an FDA 510(k) clearance for the Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter, a Separator, Automated, Blood Cell And Plasma, Therapeutic, submitted by Terumo Bct (Lakewood, US). The FDA issued a Cleared decision on September 11, 2015, 113 days after receiving the submission on May 21, 2015. This device falls under the Gastroenterology & Urology review panel.
| 510(k) Number | K151368 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 21, 2015 |
| Decision Date | September 11, 2015 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | — |