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FDA 510(k)

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

K-Number: K161261 · 2017-05-12

ApplicantGenea Biomedx Pty, Ltd.
Decision Date2017-05-12
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase is a medical device manufactured by Genea Biomedx Pty, Ltd.. It received FDA 510(k) clearance on 2017-05-12 under approval number K161261. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase?

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase is a medical device that received FDA 510(k) clearance on 2017-05-12. It is manufactured by Genea Biomedx Pty, Ltd.. The 510(k) number is K161261.

When was Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase approved by the FDA?

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase received FDA 510(k) clearance on 2017-05-12, under approval number K161261.

What company makes Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase?

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase is manufactured by Genea Biomedx Pty, Ltd..

What is the FDA product code for Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase?

The FDA product code for Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase is MQL.

Related Clinical Trials

NCT07464275 Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction COMPLETED NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Genea Biomedx Pty, Ltd.

K171736Geri Embryo Incubator and Geri Dish K170498Gems Oocyte Retrieval Buffer ORB-20, ORB-50 K162409Gems Vitrification Set, Gems Warming Set K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish K180304Geri Embryo Incubator and Geri Dish

Related Devices (Code: MQL)

K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd. K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty. , Ltd. K160863PBS(-), Phosphate Buffered SalineKitazato Biopharma Co., Ltd. K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitWilliam A. Cook Australia Pty. , Ltd. K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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