510(k) Blood Establishment Computer Software - 2019
Software is listed by clearance date in reverse chronological order.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| BK190333 | Terumo BCT, Inc. 10810 West Collins Avenue Lakewood, CO 80215 |
Terumo Operational Medical Equipment Software (TOMEs), Version 7.1 | 12/3/2019 |
| BK190361 | Alliance Technologies, LLC. 1552 West Griswold Road Phoenix, AZ 85021 |
BloodRelay 1.0.0 | 9/17/2019 |
| BK180275 | Bio-Rad Medical Diagnostics GmbH Bio-Rad Laboratories, Inc. 6565 185th Avenue, NE. Redmond, WA 98052 |
IH-Com V5.0 | 3/21/2019 |
| BK180258 | Terumo BCT, Inc. 10811 West Collins Avenue Lakewood, CO 80215 |
Vista Information System | 1/18/2019 |