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FDA 510(k)

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

K-Number: K180073 · 2018-08-29

ApplicantShenzhen Vitavitro Bio-Tech Co., Ltd.
Decision Date2018-08-29
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vitavitro Bio-Tech Co., Ltd.. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K180073. 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 Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set?

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Shenzhen Vitavitro Bio-Tech Co., Ltd.. The 510(k) number is K180073.

When did Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set receive FDA 510(k) clearance?

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set received FDA 510(k) clearance on 2018-08-29, under 510(k) number K180073.

Who is the listed applicant for Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set?

The FDA 510(k) record lists Shenzhen Vitavitro Bio-Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set?

The FDA product code for Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set is MQL.

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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