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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.

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  5. Substantially Equivalent 510(k) Device Information
  6. 510(k) Blood Establishment Computer Software - 2021
  1. Substantially Equivalent 510(k) Device Information

510(k) Blood Establishment Computer Software - 2021

Software is listed by clearance date in reverse chronological order.

 

510(k) Number Applicant Device Name Decision Date
BK210572 Immucor GTI Diagnostics Inc.
20925 Crossroads Circle, Suite 200
Waukesha, WI 53186
BK210572 - MATCH IT! Antibody 11/19/2021
BK210620 Alliance Technologies, LLC
1552 West Griswold Road
Phoenix, AZ 85021
BloodRelay 1.1.0 10/4/2021
BK210607 SCC Soft Computer
5400 Tech Data Drive
Clearwater, FL 33760
SoftDonor Version 4.5.5.0 9/14/2021
BK210593 BIQ-Health Solutions, Lda.
Rua Ferreira de Castro, 20 C
Barcarena, Lisbon 2730-081
Portugal
BTrac 8/13/2021
BK210556 Sunquest Information Systems, Inc.
3300 Sunrise Drive
Tucson, AZ 85718
Sunquest Transfusion Manager™ Version 3.0 4/16/2021
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