510(k) K133387

ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED by Origio A/S — Product Code MQL

K133387 is an FDA 510(k) premarket notification submitted by Origio A/S for the device "ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED". The FDA issued a decision of Substantially Equivalent on April 29, 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.