510(k) K200272

Terragene Chemdye by Terragene S.A. — Product Code JOJ

K200272 is an FDA 510(k) premarket notification submitted by Terragene S.A. for the device "Terragene Chemdye". The FDA issued a decision of Substantially Equivalent on June 30, 2020. The device falls under product code JOJ (Indicator, Physical/Chemical 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.