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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
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  5. Substantially Equivalent 510(k) Device Information
  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
BK241061 IT Synergistics, LLC
115 Tree Street
Flowood, MS 39232		 bexWISE API v1.0 10/25/2024
BK241081 Epic Systems Corporation
1979 Milky Way
Verona, WI 53593		 Blood Product Administration Module (BPAM 4-2023) 8/21/2024
BK241080 Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071		 ImmuLINK (v3.2) 8/6/2024
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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