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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
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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