FDA 510(k)

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

Numéro K : K161261 · 2017-05-12

Date de décision2017-05-12

Code produitMQL

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Genea Biomedx Pty, Ltd.. The 510(k) number is K161261.

When did Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase receive FDA 510(k) clearance?

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

Who is the listed applicant for Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase?

The FDA 510(k) record lists Genea Biomedx Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Autres dossiers indiquant Genea Biomedx Pty, Ltd. en tant que demandeur

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

Dispositifs connexes (Code : MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

Source officielle

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