The following data is part of a premarket notification filed by Terumo Bct, Inc with the FDA for Automated Blood Cell Separator -filtration.
| Device ID | BK010046 |
| 510k Number | BK010046 |
| Device Name: | Automated Blood Cell Separator -Filtration |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | Terumo BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 US |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-29 |
| Decision Date | 2002-09-18 |