The following data is part of a premarket notification filed by Terumo Bct with the FDA for Spectra Optia Apheresis System, Spectra Optia Exchange Set (with Ac Connection), Spectra Optia Ac Connection Adapter.
| Device ID | K151368 |
| 510k Number | K151368 |
| Device Name: | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | TERUMO BCT 10811 W. COLLINS AVENUE Lakewood, CO 80215 -4415 |
| Contact | Nicholas Wong |
| Correspondent | Nicholas Wong TERUMO BCT 10811 W. COLLINS AVENUE Lakewood, CO 80215 -4415 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-21 |
| Decision Date | 2015-09-11 |
| Summary: | summary |