510(k) K231383

Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) by Terragene S.A. — Product Code FRC

K231383 is an FDA 510(k) premarket notification submitted by Terragene S.A. for the device "Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)". The FDA issued a decision of Substantially Equivalent on September 18, 2024. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Terragene S.A. has at least 8 other 510(k) clearances on record.