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FDA 510(k)

Gems Oocyte Retrieval Buffer ORB-20, ORB-50

K-Number: K170498 · 2017-09-28

ApplicantGenea Biomedx Pty, Ltd.
Decision Date2017-09-28
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Gems Oocyte Retrieval Buffer ORB-20, ORB-50 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 2017-09-28 under 510(k) number K170498. 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 Oocyte Retrieval Buffer ORB-20, ORB-50?

Gems Oocyte Retrieval Buffer ORB-20, ORB-50 is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Genea Biomedx Pty, Ltd.. The 510(k) number is K170498.

When did Gems Oocyte Retrieval Buffer ORB-20, ORB-50 receive FDA 510(k) clearance?

Gems Oocyte Retrieval Buffer ORB-20, ORB-50 received FDA 510(k) clearance on 2017-09-28, under 510(k) number K170498.

Who is the listed applicant for Gems Oocyte Retrieval Buffer ORB-20, ORB-50?

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 Oocyte Retrieval Buffer ORB-20, ORB-50?

The FDA product code for Gems Oocyte Retrieval Buffer ORB-20, ORB-50 is MQL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07522281Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI CyclesNOT_YET_RECRUITING

Other records listing Genea Biomedx Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishK180304Geri Embryo Incubator and Geri DishK171736Geri Embryo Incubator and Geri DishK162409Gems Vitrification Set, Gems Warming SetK161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

Related Devices (Code: MQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin 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 CorporationK242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

Official Source

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

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