The following data is part of a premarket notification filed by Terumo Bct, Inc with the FDA for Automated Blood Cell Separators.
Device ID | BK150321 |
510k Number | BK150321 |
Device Name: | Automated Blood Cell Separators |
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) Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-17 |
Decision Date | 2015-10-16 |