Automated Blood Cell Separators
Separator, Automated, Blood Cell, Diagnostic
TERUMO Corporation
The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Automated Blood Cell Separators.
Pre-market Notification Details
| Device ID | BK120012 |
| 510k Number | BK120012 |
| Device Name: | Automated Blood Cell Separators |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | TERUMO Corporation 10811 W. Collins Avenue 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 | 2012-02-29 |
| Decision Date | 2012-07-09 |
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