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FDA 510(k)

Sydney IVF Culture Oil

K-Number: K170257 · 2017-02-24

ApplicantWilliam A. Cook Australia Pty. , Ltd.
Decision Date2017-02-24
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sydney IVF Culture Oil is the device name listed in this FDA 510(k) record. The listed applicant is William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K170257. 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 Sydney IVF Culture Oil?

Sydney IVF Culture Oil is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is William A. Cook Australia Pty. , Ltd.. The 510(k) number is K170257.

When did Sydney IVF Culture Oil receive FDA 510(k) clearance?

Sydney IVF Culture Oil received FDA 510(k) clearance on 2017-02-24, under 510(k) number K170257.

Who is the listed applicant for Sydney IVF Culture Oil?

The FDA 510(k) record lists William A. Cook Australia Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sydney IVF Culture Oil?

The FDA product code for Sydney IVF Culture Oil is MQL.

Other records listing William A. Cook Australia 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.

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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

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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