The following data is part of a premarket notification filed by Caridianbct, Inc. with the FDA for Spectra Optia Apheresis System.
| Device ID | K113480 |
| 510k Number | K113480 |
| Device Name: | SPECTRA OPTIA APHERESIS SYSTEM |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | CARIDIANBCT, INC. 10811 W. COLLINS AVE Lakewood, CO 80215 |
| Contact | Tina O'brien |
| Correspondent | Tina O'brien 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 | 2011-11-23 |
| Decision Date | 2012-01-20 |
| Summary: | summary |