510(k) K191021

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye by Terragene S.A. — Product Code FRC

K191021 is an FDA 510(k) premarket notification submitted by Terragene S.A. for the device "Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye". The FDA issued a decision of Substantially Equivalent on September 13, 2019. 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.