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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assayed Quality Control Material For Clinical Microbiology Assays
510(k) Number K242492
Device Name Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
Applicant
Techno-Path Manufacturing , Ltd.
Fort Henry Business Park,
Ballina
Co. Tipperary,  IE V94 FF1P
Applicant Contact Alan McDonagh
Correspondent
Techno-Path Manufacturing , Ltd.
Fort Henry Business Park,
Ballina
Co. Tipperary,  IE V94 FF1P
Correspondent Contact Alan McDonagh
Regulation Number866.3920
Classification Product Code
QCH  
Subsequent Product Code
KSF  
Date Received08/21/2024
Decision Date 12/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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