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FDA 510(k) Applications Submitted by Genea Biomedx Pty Ltd
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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