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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K251122
Device Name Terragene® Bionova® BT20 Biological Indicator
Applicant
Terragene
Ruta Nacional N° 9, Km 280,
Parque Industrial Micropi
Alvear,  AR 2130
Applicant Contact Hernando Carrizo
Correspondent
Terragene
Ruta Nacional N° 9, Km 280,
Parque Industrial Micropi
Alvear,  AR 2130
Correspondent Contact Hernando Carrizo
Regulation Number880.2800
Classification Product Code
FRC  
Date Received04/11/2025
Decision Date 08/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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