510(k) K231169

STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) by Plasmapp Co,., Ltd. — Product Code MLR

K231169 is an FDA 510(k) premarket notification submitted by Plasmapp Co,., Ltd. for the device "STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)". The FDA issued a decision of Substantially Equivalent on May 25, 2023. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Plasmapp Co,., Ltd. has at least 7 other 510(k) clearances on record.