510(k) Blood Establishment Computer Software - 2020
Software is listed by clearance date in reverse chronological order.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| BK200531 | SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760 |
SoftBank Version 25.6.1.0 | 12/18/2020 |
| BK200526 | Headspring Healthcare, Inc. 10415 Morado Circle, Suite 300 Austin, TX 78759 |
National Donor Deferral Registry (NDDR) and Cross Donation Check System (CDCS) | 11/18/2020 |
| BK200513 | Hemasoft Software S.L. Speed to Market, Inc. P.O. Box 3018 Nederland, CO 80466 |
e-Delphyn LIS Donor | 11/9/2020 |
| BK200517 | Biomat USA, Inc. 2410 Lillyvale Avenue Los Angeles, CA 90032 |
GDS (Grifols Donation System) V2.0 | 11/5/2020 |
| BK200515 | Hemasoft Software S.L. Speed to Market, Inc. P.O. Box 3018 Nederland, CO 80466 |
e-Delphyn Donor version 11.0.0.1 | 11/5/2020 |
| BK200512 | ARC-One Solutions, LLC 7901 Riviera Boulevard Miramar, FL 33023 |
Regulated Software Application (RSA), Version 2.0 | 10/15/2020 |
| BK200491 | Carter BloodCare 2205 Highway 121 Bedford, TX 76021 |
iWeBB electronic Laboratory Information System (iWeBB-eLIS) v1.0.0 | 7/29/2020 |
| BK200479 | WellSky Corporation 1300 Switzer Road Overland Park, KS 66210 |
WellSky Blood - Emergency Issue 2020 R1 | 6/12/2020 |
| BK200482 | Epic Systems Corporation One Embarcadero Center, 30th Floor San Francisco, CA 94111 |
Blood Product Administration Module Version 3-2020 | 6/10/2020 |
| BK200456 | Kedrion SpA Parker Plaza, 11th Floor 400 Kelby Street Fort Lee, NJ 07024 |
GeTraP | 4/20/2020 |
| BK190430 | CSL Plasma 900 Broken Sound Parkway NW #400 Boca Raton, FL 33487 |
Anti-D Donor Management and Inventory System (ADIMS) | 3/11/2020 |