510(k) K133912

ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO by Origio A/S — Product Code MQL

K133912 is an FDA 510(k) premarket notification submitted by Origio A/S for the device "ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO". The FDA issued a decision of Substantially Equivalent on May 14, 2014. 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.