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  6. 510(k) Blood Establishment Computer Software - 2024
  1. Substantially Equivalent 510(k) Device Information

510(k) Blood Establishment Computer Software - 2024

Software is listed by clearance date in reverse chronological order.

510(k) Number Applicant Device Name Decision Date
BK241069 Carter BloodCare
2205 Highway 121 South
Bedford, TX 76021
Blood Bank Information Management System (BBIMS) v3.01 7/9/2024
BK241062 Haemonetics Corporation
125 Summer Street
Boston, MA 02110
BloodTrack Software 4.16.0 6/21/2024
BK230958 eDonorSoft, LLC
1619 Whitfield Street
Sugarland, TX 77479
HemDonER 1.0.1 5/31/2024
BK230814 Life Plasma, Inc.
5438 Perkiomen Avenue
Reading, PA 19606
SmartDMS 4/16/2024
BK231036 Haemonetics Corporation
125 Summer Street
Boston, MA 02110
NexLynk DMS® Donor Management System 4.10.0 3/15/2024
 
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