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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name assayed external control material for microbiology nucleic acid amplification (nat) assays for blood donor screening.
510(k) Number BK251300
Tradename Procleix Plasmodium Quality Control
Device Name A device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Original Applicant
Grifols Diagnostic Solutions Inc.
10808 willow court
san diego,  CA  92127
Regulation Number866.3920
Classification Product Code
QTM  
Date Received11/24/2025
Decision Date 03/26/2026
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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