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  1. Approved Blood Products

510(k) Blood Establishment Computer Software - 2017

Software is listed by clearance date in reverse chronological order.

510(k) Number Applicant Device Name Decision Date
BK160071 STRATEC Biomedical UK Limited
STRATEC Biomedical USA, Inc.
98 Main Street, Suite 205
Southington, CT 06489
Aurora Enterprise 10/30/2017
BK160017 One Lambda, Inc.
21001 Kittridge Street
Canoga Park, CA 91303
HLA Fusion™ Software Version 4.0 03/08/2017