510(k) K173624

ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) by Origio A/S — Product Code MQL

K173624 is an FDA 510(k) premarket notification submitted by Origio A/S for the device "ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)". The FDA issued a decision of Substantially Equivalent on March 2, 2018. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Origio A/S has at least 10 other 510(k) clearances on record.