Genea Biomedx Pty, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | June 7, 2018 |
| K180304 | Geri Embryo Incubator and Geri Dish | April 20, 2018 |
| K171736 | Geri Embryo Incubator and Geri Dish | November 15, 2017 |
| K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | September 28, 2017 |
| K162409 | Gems Vitrification Set, Gems Warming Set | May 24, 2017 |
| K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitB | May 12, 2017 |