FDA 510(k) Applications Submitted by Origio a/s

FDA 510(k) Number Submission Date Device Name Applicant
K200815 03/30/2020 VitriGuard ORIGIO a/s
K120136 01/17/2012 EMBRYOGEN ORIGIO A/S
K180740 03/22/2018 VitriGuard ORIGIO a/s
K162833 10/11/2016 VitriGuard ORIGIO A/S
K100367 02/12/2010 MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 ORIGIO A/S
K140317 02/10/2014 EMBRYOGEN ORIGIO A/S
K161547 06/03/2016 Transem and EchoGen Embryo Transfer Catheters ORIGIO A/S
K172197 07/21/2017 SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS ORIGIO a/s
K152932 10/05/2015 BlastGen ORIGIO A/S
K133387 11/05/2013 ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED ORIGIO A/S
K153267 11/12/2015 ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash ORIGIO A/S
K173624 11/24/2017 ORIGIO« HandlingÖ without phenol red (Cat. No. 8310), ORIGIO« HandlingÖ with phenol red (Cat. No. 8311) Origio a/s
K133707 12/04/2013 SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS ORIGIO A/S
K133912 12/23/2013 ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO ORIGIO A/S


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