Medical Device Manufacturer · AU , Sydney

Genea Biomedx Pty, Ltd.

6 submissions · 6 cleared · Since 2017

Total

Cleared

Denied

Genea Biomedx Pty, Ltd. — FDA 510(k) Submissions

Genea Biomedx Pty, Ltd. has submitted 6 FDA 510(k) premarket notifications since 2017, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Media, Reproductive, Accessory, Assisted Reproduction . Use the specialty filter in the sidebar to narrow results.

6 devices

1–6 of 6

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish

K180188 · MQG Accessory, Assisted... · Obstetrics & Gynecology

Jun 2018 135d

Geri Embryo Incubator and Geri Dish

K180304 · MQG Accessory, Assisted... · Obstetrics & Gynecology

Apr 2018 77d

Geri Embryo Incubator and Geri Dish

K171736 · MQG Accessory, Assisted... · Obstetrics & Gynecology

Nov 2017 156d

Gems Oocyte Retrieval Buffer ORB-20, ORB-50