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  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents - 2026

This list includes cleared 510(k) submissions for 2026 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
BK251168Arteriocyte Medical Systems, Inc. DBA Isto Biologics
Hopkinton, MA 01748		Precise Cell Concentration System02/03/2026 
BK251245Grifols Diagnostic Solutions Inc.
San Diego, CA 92127		Procleix® WNV/ Babesia Quality Control01/02/2026
BK251207Techno-Path Manufacturing Ltd.
Ireland		Multichem ID-HIV p2401/02/2026
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