The following data is part of a premarket notification filed by Caridianbct, Inc. with the FDA for Spectra Optia R Apheresis System.
| Device ID | K103090 |
| 510k Number | K103090 |
| Device Name: | SPECTRA OPTIA R APHERESIS SYSTEM |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | CARIDIANBCT, INC. 10811 W. COLLINS AVE Lakewood, CO 80215 |
| Contact | Patti Arndt |
| Correspondent | Patti Arndt CARIDIANBCT, INC. 10811 W. COLLINS AVE Lakewood, CO 80215 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-19 |
| Decision Date | 2010-11-19 |
| Summary: | summary |