FDA 510(k) Applications Submitted by Kea Dent

FDA 510(k) Number Submission Date Device Name Applicant
K180188 01/23/2018 Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish Genea Biomedx Pty Ltd
K180304 02/02/2018 Geri Embryo Incubator and Geri Dish Genea Biomedx Pty Ltd
K170498 02/17/2017 Gems Oocyte Retrieval Buffer ORB-20, ORB-50 Genea Biomedx Pty Ltd
K161261 05/04/2016 Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase Genea Biomedx Pty Ltd
K171736 06/12/2017 Geri Embryo Incubator and Geri Dish Genea Biomedx Pty Ltd
K162409 08/29/2016 Gems Vitrification Set, Gems Warming Set GENEA BIOMEDX PTY LTD


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