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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