510(k) K163646

Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator by Terragene S.A. — Product Code FRC

K163646 is an FDA 510(k) premarket notification submitted by Terragene S.A. for the device "Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator". The FDA issued a decision of Substantially Equivalent on November 2, 2017. 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.