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FDA 510(k)

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

K-Number: K212410 · 2022-02-01

ApplicantShenzhen Vitavitro Biotech Co., Ltd.
Decision Date2022-02-01
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K212410. 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 Sperm Washing Medium, VitaVitro Sperm Gradient Medium?

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K212410.

When did VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium receive FDA 510(k) clearance?

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium received FDA 510(k) clearance on 2022-02-01, under 510(k) number K212410.

Who is the listed applicant for VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium?

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

What is the FDA product code for VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium?

The FDA product code for VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium is MQL.

Other records listing Shenzhen Vitavitro Biotech Co., 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.

K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer MediumK1910631-Step Culture Medium

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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