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  6. 510(k) Blood Establishment Computer Software - 2020
  1. Substantially Equivalent 510(k) Device Information

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
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
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