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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 quality control material for clinical microbiology assays
510(k) Number BK251207
Tradenames Multichem ID-HIV p24 (09915494190), Multichem ID-HIV p24 (SR1111U), Multichem ID-HIV p24 Mini Kit (SR1111MU)
Device Name Assayed quality control material for clinical microbiological assays
Original Applicant
Techno-Path Manufacturing Ltd.
fort henry business park
ballina
co. tipperary,  Munster,  V94 FF1P, 
Regulation Number866.3920
Classification Product Code
QCH  
Date Received05/13/2025
Decision Date 01/02/2026
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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