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  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents - 2024

This list includes cleared 510(k) submissions for 2024 for which we have supporting documents available, and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change.

The clearances are listed by clearance date in reverse chronological order.

510(k) Number Applicant Device Name Decision Date
BK230825 Fresenius Kabi AG ALYX 2RBC-LR Kit 4/5/2024
BK230968 Reapplix ApS 3C OrthoPatch Device 3/29/2024
BK231036 Haemonetics Corporation
Boston, MA
NexLynk DMS® Donor Management System 4.10.0 03/15/2024
BK231035 Terumo BCT
Lakewood, CO
Rika Plasma Donation System (V2.1) 03/07/2024
BK231016 Aeon Biotherapeutics Corp.
Taiwan
Aeon ACKit 02/16/2024
 
 
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