510(k) K221641

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) by Terragene S.A. — Product Code FRC

K221641 is an FDA 510(k) premarket notification submitted by Terragene S.A. for the device "Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)". The FDA issued a decision of Substantially Equivalent on February 28, 2023. 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.