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  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
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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