The following data is part of a premarket notification filed by Terumo Bct with the FDA for Automated Blood Cell Separators.
| Device ID | BK130065 |
| 510k Number | BK130065 |
| Device Name: | Automated Blood Cell Separators |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | TERUMO BCT 10811 W. Collins Ave Lakewood, CO 80215 |
| 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 | 2013-10-23 |
| Decision Date | 2014-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35020583103000 | BK130065 | 0 |
| 05020583103009 | BK130065 | 0 |