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  6. Cleared 510(k) Submissions with Supporting Documents - 2025
  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents - 2025

This list includes cleared 510(k) submissions for 2025 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) NumberApplicantDevice NameDecision Date
BK231018Sunphoria Co.,Ltd
Taiwan
AHC Platelet Concentrate Separator1/10/2025
BK241148Roche Diagnostics
Indianapolis, IN
cobas pro serology solution (applicable to)
a) Elecsys Syphilis and
b) Elecsys Anti-CMV
1/10/2025
BK210601Immucor, Inc.
Norcross, GA
Echo Lumena1/8/2025
BK210604Immucor, Inc.
Norcross, GA
Complement Control Cells1/8/2025
BK210608Immucor, Inc.
Norcross, GA
Galileo Echo1/8/2025
BK241067Immucor GTI Diagnostics, Inc. 
Waukesha, WI
MatchX1/2/2025
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