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 |