K181049 is an FDA 510(k) clearance for the Spectra Optia Apheresis System, a Separator, Automated, Blood Cell And Plasma, Therapeutic, submitted by Terumobct, Inc. (Lakewood, US). The FDA issued a Cleared decision on November 1, 2018, 195 days after receiving the submission on April 20, 2018. This device falls under the Gastroenterology & Urology review panel.
| 510(k) Number | K181049 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 20, 2018 |
| Decision Date | November 01, 2018 |
| Days to Decision | 195 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | — |